Biomarker Insights[JOURNAL]
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200 papers
Salivary Biomarkers of Inflammation in Patients With Chronic Non-Specific Low Back Pain.
Injeyan HS, Teodorczyk-Injeyan JA, Hogg-Johnson S … +3 more , Rashed S, Lee J, Harris G
Biomark Insights · 2025 · PMID 40735033 · Full text
BACKGROUND: Chronic non-specific low back pain (CNSLBP) is a debilitating condition with unclear underlying mechanisms. The presence of systemic biomarkers associated with inflammation in nonspecific low back pain (NSLBP...
BACKGROUND: Chronic non-specific low back pain (CNSLBP) is a debilitating condition with unclear underlying mechanisms. The presence of systemic biomarkers associated with inflammation in nonspecific low back pain (NSLBP) has been inconsistently reported primarily through invasive blood sampling. OBJECTIVE: This study evaluates the use of saliva as an alternative medium for assessing inflammatory biomarker levels in patients with CNSLBP. DESIGN: Prospective cross-sectional pilot study. METHODS: Twenty-five patients with CNSLBP and 25 age and sex matched asymptomatic participants were selected according to specific inclusion and exclusion criteria. The primary outcome was determination of the levels of inflammatory biomarkers in unstimulated saliva samples of CNSLBP patients relative to controls using Luminex™ 200 technology. Secondary outcomes were pain, disability and anxiety/stress levels of participants. RESULTS: In CNSLBP patients, 9 biomarkers interferon γ (IFNγ), interleukin-2 (IL-2), IL-4, IL-5, IL-10, IL-13, IL-12p40, IL-12p70, and tumor necrosis factor α (TNFα) were comparable to controls ( = .25-.94). However, 4 pro-inflammatory mediators were significantly elevated, exhibiting medium to large effect sizes: IL-1β ( = .028, Cohen's = 1.62), IL-6 ( = .001, = 1.0), IL-8 ( = .002, = 0.86), and MCP-1 ( = .001, = 0.77). Additionally, IL-1Ra levels were significantly higher, though with a small effect size ( = .03, = 0.43). A significant correlation ( = .02) was observed between VAS pain scores and MCP-1 levels. CONCLUSION: Saliva represents a viable medium for assessing key inflammatory biomarkers in patients with chronic non-specific low back pain (CNSLBP). Elevated levels of proinflammatory cytokines, IL-1, IL-6, IL-8, and the nociceptive chemokine MCP-1 were observed in comparison to asymptomatic controls, with MCP-1 showing a positive correlation with self-reported pain intensity. Future studies utilizing unstimulated saliva samples may further investigate changes in inflammatory biomarker levels to monitor treatment outcomes.
The Genoa Vascular Biobank: A Today Resource for Future Perspectives in Vascular Research.
Barisione C, Mena Vera JM, Ivaldo C … +10 more , Ortona S, Ferrari PF, Visconti P, Paudice M, Bastianon M, Melani C, Mozzetta G, Vellone V, Pratesi G, Palombo D
Biomark Insights · 2025 · PMID 40661258 · Full text
BACKGROUND: Biological knowledge and patient care have been significantly improved by the emergence of big data analysis and -omics sciences, requiring high quality standards for biospecimen and data collection. Biobanks...
BACKGROUND: Biological knowledge and patient care have been significantly improved by the emergence of big data analysis and -omics sciences, requiring high quality standards for biospecimen and data collection. Biobanks are complex and dynamic units designated to fulfill these needs. OBJECTIVES: The Genoa Vascular Biobank (GTB-VD) is a collaborative network between the IRCCS Ospedale Policlinico San Martino (Centre of Biological Resources), and the University of Genoa (Vascular and Endovascular Surgery Unit; Anatomic Pathology Unit; Laboratory of Clinical and Experimental Vascular Biology). This work describes workflow, ethic and governance requirements, demographic and clinical characteristics of subjects enrolled in the GTB-VD, and the volume of open or endovascular surgical interventions. DESIGN: The GTB-VD recruits patients undergoing surgical repair for carotid artery stenosis (CS) and abdominal aortic aneurysm (AAA), enrolled on the basis of selection criteria and subdivided for pathology and type of intervention, upon informed consent. METHODS: Biospecimens comprise serum, plasma, whole blood, peripheral blood mononuclear cells, and urine (from AAA only), stored at -80°C; lesions from open surgeries are frozen and formalin fixed paraffin embedded. Samples are associated with donor's clinical data through pseudonymization to prevent patient identification. Data accuracy and sample quality are ensured by harmonized standard operative procedures. RESULTS: From 2018 to the end of 2023, 442 CS (distinguished into severe-asymptomatic or symptomatic, displaying a ratio of 5:1) and 214 AAA have been collected. CS is more frequently associated with diabetes and peripheral artery diseases, AAA with pulmonary history, and renal function impairment. Open surgery is more used for CS and endovascular for AAA. CONCLUSION: The GTB-VD, as organized, represents an "" in our Country; it supports studies to identify molecular targets and biomarkers associated with specific arteriopathy, for developing secondary prevention strategies and minimally invasive, in situ therapies. Collaborative studies and sample sharing are welcome.
A Comprehensive Description of the Roadmap to Identify and Validate a Myelin Biomarker.
Capodivento G, Visigalli D, Armirotti A … +15 more , Demichelis C, Carpo M, Fancellu R, Schirinzi E, Severi D, Franciotta D, Manganelli F, Siciliano G, Beronio A, Capello E, Lanteri P, Nobile-Orazio E, Schenone A, Benedetti L, Nobbio L
Biomark Insights · 2025 · PMID 40625699 · Full text
BACKGROUND: Demyelination and remyelination are major issues for scientists dealing with myelin disorders in both clinical and research fields. Despite that, rapid, reliable and convenient tools to monitor myelin changes...
BACKGROUND: Demyelination and remyelination are major issues for scientists dealing with myelin disorders in both clinical and research fields. Despite that, rapid, reliable and convenient tools to monitor myelin changes still lack both in central and peripheral nervous system. Given that myelin is enriched in specific lipids and proteins, it is reasonable they could represent eligible candidates as structural damage biomarkers for this characteristic membrane. Among them, we focused on sphingomyelin (SM) due to the enrichment in myelin and because it is easily measurable in different biological matrices. OBJECTIVE: Depicting the roadmap to identify and validate SM dosage as a myelin biomarker useful for pre-clinical and clinical practice. DESIGN: This study adheres to STROBE guidelines for observational cross-sectional studies on human patients and to ARRIVE guidelines for animal models. METHOD: Following the recommendations of the Society for CSF Analysis and Clinical Neurochemistry, we describe the stepwise process to validate SM as a myelin biomarker, starting from the optimization of the fluorescence-based assay and analytical validation in experimental models until clinical and pathological validation in biological fluids of neurological patients. RESULTS: SM dosage monitors myelination, demyelination, remyelination and even small myelin changes associated to myelin pathology and pharmacological treatments in experimental models. SM is detectable in human biological fluids and informative of myelin damage in the CSF of neurological patients. SM dosage identifies myelin breakdown in the CSF of patients affected by Guillain-Barrè Syndrome (GBS) and Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), identifying disease activity, axonal from demyelinating variants, and avoiding misdiagnosis. CONCLUSION: SM dosage displayed extremely promising real-word performances being able to identify, monitor and stage myelin pathology. Given that it is simple, inexpensive and easily adaptable to routine use in any hospital setting, it might rapidly progress to the implementation and impact on clinical outcomes.
Pro-Inflammatory Cytokines in Patients With Chronic Phase-Chronic Myeloid Leukaemia Treated With Imatinib: Any Role in the Monitoring of Treatment Response?
Taiwo KA, Ahmed IO, Asafa MA … +5 more , Olarewaju OJ, Omoyiola OA, Oguns OO, Owojuyigbe TO, Bolarinwa RA
Biomark Insights · 2025 · PMID 40606776 · Full text
BACKGROUND: Cancers cause changes in the levels of inflammatory cytokines by inhibiting or promoting their production thus affecting the immune system. The measurement of serum levels of cytokines may be useful in assess...
BACKGROUND: Cancers cause changes in the levels of inflammatory cytokines by inhibiting or promoting their production thus affecting the immune system. The measurement of serum levels of cytokines may be useful in assessing these immunological changes and invariably assessing cancer status. OBJECTIVES: To investigate the effect of imatinib mesylate (glivec) on the serum levels of interleukins (IL-6 and IL-10), and C-reactive protein (CRP) in patients with chronic phase chronic myeloid leukaemia (CP-CML). DESIGN: This prospective cohort study included 26 imatinib naïve CP-CML patients with no other co-morbidities and 26 age and sex-matched healthy controls. METHOD: Serum levels of interleukins (IL6 and 10) and CRP were determined using the ELISA method at recruitment for both patients and controls and repeated for the CML patients at 3 months into imatinib therapy. RESULTS: The mean serum levels of IL-6 and CRP were significantly higher in CP-CML than in the controls at recruitment 439.83 ± 167.52 versus 39.62 ± 10.11 pg/ml, ( = 8.720 ⩽ .0001), (8.45 ± 2.88 vs 2.86 ± 1.08 mg/l; = 6.729 ⩽ .0001) respectively. In contrast, the mean of the IL-10 in the controls (36.63 ± 12.43) was noticed to be significantly higher than the patients (22.88 ± 4.76 vs 36.63 ± 12.43 pg/ml; = -3.851 = .003). Interestingly, there was a significant drop in the serum levels of IL-6 (439.83 ± 167.52 vs 46.85 ± 14.48 pg/ml, ( = 8.055 ⩽ .0001) and CRP (8.45 ± 2.88 mg/l vs 4.24 ± 1.57; = 4.305 = .0001) in the CML subjects 3 months into imatinib therapy. Only IL-10 had a non-significant drop in the CML subjects after 3 months of imatinib therapy. Method validation of these biomarkers was done using the Receiver operating characteristic (ROC) curve which revealed an area under the curve (AUC) of 1.000 for both IL-6 and CRP and 0.152 for IL-10. CONCLUSION: The study has concluded that treatment naïve CML is associated with a significant elevation of pro-inflammatory cytokines (IL-6 and CRP) and treatment with imatinib led to a significant decline in the serum levels of these markers suggesting that IL-6 and CRP could be useful as adjunct in the monitoring of CML treatment.
-derived Signature Protein(s) in Murine Vaginal Lavage Fluid: Investigating the Underlying factors of Infertility as a Consequence of Sperm Impairing Bacterium.
Jawanda IK, Soni T, Kumari S … +1 more , Prabha V
Biomark Insights · 2025 · PMID 40453328 · Full text
BACKGROUND: Bacterial infections are often an overlooked factor in female infertility. has been identified as the predominant vaginal pathogen in infertile women, with a prevalence of 57.33%. Previous studies showed tha...
BACKGROUND: Bacterial infections are often an overlooked factor in female infertility. has been identified as the predominant vaginal pathogen in infertile women, with a prevalence of 57.33%. Previous studies showed that induces infertility in mice by sperm impairment, suggesting its asymptomatic vaginal colonization creates a hostile environment for sperm. While sperm immobilization factor (SIF) from culture supernatant has been identified, its production within host's environment remained unexplored. OBJECTIVE: To unveil -derived signature protein(s) in vaginal lavage fluid (VLf). DESIGN: Mass spectrometry combined with experimental studies. METHODS: VLf was obtained from female mice administered either with sperm immobilizing (test group) or PBS alone (control group) and analyzed using nano-LC-MS/MS, gel filtration chromatography, SDS-PAGE, functional assays, and in silico studies. RESULTS: Nano-LC-MS/MS yielded 5 distinct bacterial proteins in test group and no bacterial protein in control. Elution profile of test VLf revealed a single peak and indicated 1 protein band (~36 kDa) using SDS-PAGE that aligned with GMP reductase. VLf-protein showed impairment of sperm motility and viability in concentration-dependent manner and disrupted sperm morphology. Binding studies using FITC-labeled VLf-protein depicted presence of green fluorescence over entire surface of mouse spermatozoa. These results were akin to SIF, already isolated and characterized in our laboratory, from culture supernatant of , causing sperm impairment and hence, designated as vaginal lavage fluid-derived sperm immobilization factor (VLf-SIF). Through in silico analysis, superimposition of VLf-SIF and SIF, already known to show sequence homology to cysteine-tRNA ligase, revealed close structural alignment. Molecular docking analysis depicted energetically favorable binding between VLf-SIF and spermatozoa surface protein (Heat shock-related 70 kDa protein 2). CONCLUSION: This study provides novel evidence of sperm-impairing signature proteins as key mediators of bacterial-induced infertility, paving way for diagnostic, and therapeutic advancements.
Pre-diagnostic Demographic, Lifestyle, and Health History Factors in Association with Secreted Protein Acidic and Rich in Cysteine (SPARC) Expression in Colorectal Cancer Tissue.
Zanif U, Parks J, Tai I … +6 more , Yip S, Babinszky S, Milne K, Watson P, Murphy RA, Bhatti P
Biomark Insights · 2025 · PMID 40417350 · Full text
BACKGROUND: Demographic, health history, and lifestyle factors have been associated with prognosis of colorectal cancer (CRC), but mechanisms underlying these associations remain poorly understood. A compelling mechanism...
BACKGROUND: Demographic, health history, and lifestyle factors have been associated with prognosis of colorectal cancer (CRC), but mechanisms underlying these associations remain poorly understood. A compelling mechanism involves changes in expression of tumor markers that influence treatment outcomes, such as secreted protein acidic and rich in cysteine (SPARC), lower levels of which have previously been associated with poorer CRC prognosis. OBJECTIVE: We explored the association of factors that have been previously associated with CRC prognosis with expression of SPARC in tumor tissues. DESIGN: We conducted a prospective evaluation of 50 participants of a longitudinal cohort study that went on to develop CRC. METHODS: Tumor and normal tissue cores were taken from formalin-fixed paraffin-embedded (FFPE) blocks of incident CRC cases and were used to create tissue microarrays (TMAs). Slides created from the TMAs were stained with SPARC antibodies and analyzed to calculate H-scores for both epithelial and non-epithelial components of tumor and normal tissues. H-scores were ln-transformed and analyzed in association with demographic, lifestyle, and health history factors assessed before cancer diagnosis using linear regression models. RESULTS: In CRC tumor epithelium, smoking was associated with a 0.53-fold lower level of SPARC expression ( = .054). Higher income was associated with a 1.33-fold greater level of SPARC expression in tumor non-epithelial tissue ( = .041). Higher cancer stage was associated with a 0.74-fold lower level of non-epithelial tumor SPARC expression ( = .040). In the epithelial component of normal colorectal tissues, higher fruit consumption was associated with a 2.74-fold greater SPARC H-score ( = .002). CONCLUSIONS: The associations we observed for smoking, income, and cancer stage with SPARC in tumor tissue are consistent with previously established associations of these factors with CRC prognosis. Larger studies with prognostic data are needed, but our results suggest that differences in SPARC expression may contribute to previously observed impacts of various factors on CRC prognosis.
Latest Advances in Structural Insights and Quantification Techniques for Type I Collagen Biomarkers: A path toward standardization?
Demeuse J, Mackowiak A, Grifnée E … +6 more , Massonnet P, Huyghebaert L, Dubrowski T, Peeters S, Goff CL, Cavalier E
Biomark Insights · 2025 · PMID 40417349 · Full text
With an aging population, the demand for sensitive and specific biomarkers to assess bone turnover has surged. Bone turnover involves 2 key processes: bone formation, during which Type I procollagen is cleaved into Type...
With an aging population, the demand for sensitive and specific biomarkers to assess bone turnover has surged. Bone turnover involves 2 key processes: bone formation, during which Type I procollagen is cleaved into Type I collagen and subsequently mineralized into bone, and bone resorption, during which Type I collagen is demineralized and degraded into peptides by cathepsin K. To identify biomarkers that accurately reflect these processes, extensive efforts have been made to characterize the peptides generated during both formation and resorption. Over the years, numerous biomarkers have been discovered for various disorders. However, despite their clinical utility, many of these markers lack specificity. This is due to factors such as the degradation of trimers into monomers, the coexistence of multiple peptide species arising from the unpredictable cleavage of Type I collagen/procollagen by cathepsin K and metalloproteinases, and the lack of assay standardization. Standardization is further hindered by the incomplete characterization of many of these peptides. For accurate assay development, a gold-standard technique like LC-MS/MS is essential, requiring full peptide characterization during method development. This review aims to present recent advances in the characterization of Type I collagen-derived peptides, providing a foundation for improved biomarker standardization and application in clinical practice.
Poor Abilities of Noninvasive Biomarkers to Assess Esophagogastric Varices and Portal Hypertensive Gastropathy.
Abassa KK, Guo X, Tan S … +2 more , Liang Z, Tan S
Biomark Insights · 2025 · PMID 40386244 · Full text
BACKGROUND: Noninvasive and cost-effective markers are needed to replace esophagogastroduodenoscopy in the screening for severe esophagogastric varices (EGVs) and portal hypertensive gastropathy (PHG). OBJECTIVE: This st...
BACKGROUND: Noninvasive and cost-effective markers are needed to replace esophagogastroduodenoscopy in the screening for severe esophagogastric varices (EGVs) and portal hypertensive gastropathy (PHG). OBJECTIVE: This study evaluated the performances of several commonly used fibrosis markers in assessing EGVs and PHG in cirrhosis patients. DESIGN: Retrospective cohort study. METHODS: A series of 323 patients with cirrhosis were consecutively enrolled and endoscopically followed up until variceal eradication was achieved. The Fibrosis-4 (FIB-4) score, albumin-bilirubin (ALBI) index, aspartate aminotransferase (AST)-to-alanine aminotransferase (ALT) ratio (AAR), AST-to-platelet ratio index (APRI), gamma-glutamyl transpeptidase-to-platelet ratio (GPR), and Lok score were calculated for each patient upon first admission. The performances of these markers in assessing EGVs and PHG were determined. RESULTS: In the screening for clinically relevant esophageal varices (CREVs), none of the markers showed a significant ability to differentiate CREVs from non-CREVs ( > .05). The AAR (area under the curve (AUC): 0.581, sensitivity: 52.0%, specificity: 66.1%, = .033) and the GPR (AUC = 0.596, sensitivity: 64.0%, specificity: 50.0%, = .033) fairly differentiated clinically relevant gastric varices (CRGVs) from non-CRGVs patients. Moreover, no correlation was noted between PHG and CREVs ( = .016, .778) or between PHG and CRGVs ( = -.024, = .666). Furthermore, no difference in the severity of PHG before and after variceal eradication was detected ( = .224). CONCLUSION: The studied markers revealed poor to no ability to assess EGVs or PHG. Hence, they cannot be used to substitute EGD in the screening for EGVs. Furthermore, endoscopic eradication of EGVs did not affect the severity of PHG.
Role of Procalcitonin as a Prognostic Biomarker in Hospitalized COVID-19 Patients: A Comparative Analysis.
Isha S, Raavi L, Jonna S … +27 more , Nataraja H, Craver EC, Jenkins A, Hanson AJ, Balasubramanian P, Balavenkataraman A, Tekin A, Bansal V, Reddy S, Caples SM, Khan SA, Jain NK, LaNou AT, Kashyap R, Cartin-Ceba R, Milian RD, Venegas CP, Shapiro AB, Bhattacharyya A, Chaudhary S, Kiley SP, Quinones QJ, Patel NM, Guru PK, Franco PM, Roy A, Sanghavi DK
Biomark Insights · 2025 · PMID 40386243 · Full text
BACKGROUND: Procalcitonin (PCT) is recognized as an inflammatory biomarker, often elevated in COVID-19 pneumonia alongside other biomarkers. Understanding its association with severe outcomes and comparing its predictive...
BACKGROUND: Procalcitonin (PCT) is recognized as an inflammatory biomarker, often elevated in COVID-19 pneumonia alongside other biomarkers. Understanding its association with severe outcomes and comparing its predictive ability with other biomarkers is crucial for clinical management. OBJECTIVES: This retrospective multicenter observational study aimed to investigate the association between PCT levels and adverse outcomes in hospitalized COVID-19 patients. Additionally, it sought to compare the predictive performance of various biomarkers. DESIGN: The study analyzed data from the Society of Critical Care Medicine (SCCM) Viral Infection and Respiratory Illness Universal Study (VIRUS) registry, comprising COVID-19 patients hospitalized across multiple Mayo Clinic sites between March 2020 and June 2022. METHODS: A total of 7851 adult COVID-19 patients were included. Patients were categorized into 6 groups based on the worst WHO ordinal scale. Multivariate models were constructed using peak biomarker levels within 72 hours of admission, adjusted for confounders. RESULTS: Elevated PCT levels were independently associated with increased odds of adverse outcomes, including ICU admission (adjusted odds ratio [aOR] 1.32, 95%CI 1.27-1.38), IMV requirement (aOR 1.35, 95%CI: 1.28-1.42), and in-hospital mortality (aOR 1.30, 95%CI: 1.22-1.37). A 3.48-fold increase in IMV requirement and 3.55 times increase in in-hospital mortality were noted with peak PCT ⩾ 0.25 ng/ml. Similar associations were observed with other biomarkers like NLR (AUC 0.730), CRP, IL-6, LDH (AUC 0.800), and D-dimer (AUC 0.719). Models incorporating NLR, LDH, D-dimer, and PCT demonstrated the highest predictive accuracy, with a combined model exhibiting an area under the curve (AUC) of 0.826 (95%CI 0.803-0.849). CONCLUSIONS: Higher PCT levels were significantly linked to worse outcomes in COVID-19 patients, emphasizing its potential as a prognostic marker. Biomarker-based predictive models, particularly those including PCT, showed promising utility for risk assessment and clinical decision-making. Further prospective studies are warranted to validate these findings on a larger scale.
[F]PSMA-1007 PET/MR as a Precision Biomarker for Early Detection of Biochemical Recurrence in Prostate Cancer at Very Low PSA Levels.
Lin KH, Wei TC, Shen SH … +5 more , Huang WJ, Chuang MH, Peng NJ, Huang WT, Wang YF
Biomark Insights · 2025 · PMID 40084117 · Full text
BACKGROUND: Prostate cancer (PCa) patients with biochemical recurrence (BCR) following radical prostatectomy or radiation therapy often present with very low prostate-specific antigen (PSA) levels (⩽0.5 ng/mL). Accurate...
BACKGROUND: Prostate cancer (PCa) patients with biochemical recurrence (BCR) following radical prostatectomy or radiation therapy often present with very low prostate-specific antigen (PSA) levels (⩽0.5 ng/mL). Accurate detection of recurrence at such low levels is crucial for guiding treatment decisions. OBJECTIVES: To assess the diagnostic efficacy of [F]PSMA-1007 PET/MR (PSMA-PETMR) in detecting BCR of PCa in patients with very low PSA levels. DESIGN: A prospective study conducted between May 2021 and January 2023, with data subsequently analyzed retrospectively after a 2-year follow-up. METHODS: The cohort comprised 157 PCa patients with BCR, of whom 52 had PSA levels ⩽ 0.5 ng/mL and underwent PSMA-PETMR imaging. The imaging protocol incorporated multiparametric MRI (mpMRI) and PET acquisitions, with lesion classification following PSMA-RADS version 1.0. Detection rates of recurrent lesions, including local recurrence, lymph node metastasis, and skeletal metastasis, were evaluated. RESULTS: PSMA-PETMR exhibited a 63.5% detection rate for recurrent PCa at low PSA levels, surpassing traditional diagnostic methods. Thirty-four local recurrences, 12 metastatic lymph nodes, and 4 skeletal metastases were identified. Follow-up imaging enhanced the detection rate to 73.1% by reclassifying initially equivocal findings. PSMA-PETMR influenced clinical decision-making in 17% of patients by facilitating personalized treatment strategies. CONCLUSION: PSMA-PETMR significantly improves the detection of recurrent PCa in patients with very low PSA levels, offering precise lesion localization and supporting personalized treatment approaches. Further studies are needed to optimize its clinical use and validate its long-term benefits.
Downregulation of DNAJC12 Expression Predicts Worse Survival for ER-Positive Breast Cancer Patients.
Gatti PHF, Mangone FRR, Pavanelli AC … +4 more , Nonogaki S, Osorio CABT, Capelozzi VL, Nagai MA
Biomark Insights · 2025 · PMID 40008192 · Full text
BACKGROUND: DNAJC12 (DnaJ heat shock protein family (Hsp40) member C12) encodes a member of the molecular chaperone Hsp40/DnaJ family, which are important protein folding and proteostasis regulators. Its role as a biomar...
BACKGROUND: DNAJC12 (DnaJ heat shock protein family (Hsp40) member C12) encodes a member of the molecular chaperone Hsp40/DnaJ family, which are important protein folding and proteostasis regulators. Its role as a biomarker has been studied for a limited number of cancer types. Objectives: Here, we sought to investigate the potential of DNAJC12 mRNA and protein expression as a prognostic and predictive biomarker for breast cancer (BC). METHODS: Using in silico analysis and data from immunohistochemistry analysis (IHC) of 292 samples from patients with primary BC, we determined the expression pattern and prognostic value of DNAJC12 mRNA and protein expression. RESULTS: From online publicly available data, we were able to identify the transcripts of DNAJC12 as differentially expressed in patients with different clinicopathological characteristics, such as ER status ( < .001), PR status ( < .001), HER2 status ( < .010) and molecular subtype ( ⩽ .001). We also found DNAJC12 to be a potential prognostic predictor for overall survival, disease-free survival, and responsiveness to treatment; a low DNAJC12 mRNA expression is commonly associated with a worse prognosis. Using IHC analysis, we showed that low DNAJC12 protein-level expression is also associated with a worse prognosis in patients with all subtypes of BC and patients with Luminal BC, and its expression is significantly different between patients with different tumor size classifications (T1/T2 vs T3/T4; = .013) or with different lymph node involvement (N0 vs N+; = .005). CONCLUSION: Our findings suggested a potential role for DNAJC12 as a prognostic and predictive biomarker for BC.
Endothelin-1 as a Candidate Biomarker of Systemic Sclerosis: A GRADE-Assessed Systematic Review and Meta-Analysis With Meta-Regression.
Mangoni AA, Zinellu A
Biomark Insights · 2025 · PMID 39990053 · Full text
BACKGROUND: There is an ongoing search for novel biomarkers of vascular dysfunction, extent of fibrosis and organ involvement in systemic sclerosis (SSc). OBJECTIVES: We critically appraised the studies investigating the...
BACKGROUND: There is an ongoing search for novel biomarkers of vascular dysfunction, extent of fibrosis and organ involvement in systemic sclerosis (SSc). OBJECTIVES: We critically appraised the studies investigating the circulating concentrations of endothelin-1 in SSc patients and healthy controls. DESIGN: This was a systematic review with meta-analysis. DATA SOURCES AND METHODS: We searched electronic databases (PubMed, Scopus, and Web of Science) from inception to 15 June 2024. We assessed the risk of bias and the certainty of evidence using the JBI Critical Appraisal Checklist and GRADE, respectively. RESULTS: Endothelin-1 concentrations were significantly higher in SSc patients than in controls (26 studies; standardised mean difference, SMD = 0.98, 95% CI 0.73-1.23, < .001; moderate certainty of evidence). In SSc patients, there were no significant differences in endothelin-1 concentrations between those with limited and diffuse cutaneous SSc (10 studies; SMD = 0.32, 95% CI -0.07 to 0.71 = .11; very low certainty), and with and without digital ulcers (5 studies; SMD = 0.82, 95% CI -0.06 to 1.69, = .066; very low certainty), pulmonary arterial hypertension (7 studies; SMD = 0.22, 95% CI -0.01 to 0.45, = .066; very low certainty) or interstitial lung disease (3 studies; SMD = 0.09, 95% CI -0.18 to 0.35, = .51; very low certainty). There was limited evidence in SSc patients with different video capillaroscopy pattern and telangiectasias. Subgroup and meta-regression analyses showed significant associations between the effect size and geographical location (studies investigating SSc patients and controls), year of publication (studies investigating SSc patients with limited and diffuse cutaneous SSc), and biological matrix assessed (studies investigating SSc patients with and without digital ulcers). CONCLUSION: The results of this systematic review and meta-analysis highlight the potential role of endothelin-1 as a candidate biomarker of SSc. Further research is warranted to determine the utility of measuring endothelin-1 in SSc subgroups with different extent of fibrosis and organ involvement. REGISTRATION: PROSPERO registration number - CRD42024566461.
A Cohort Study on Dual Predictive Markers of Immune Combination Therapy for Advanced Non-Small Cell Lung Cancer.
Zheng M, Hu M, Liu Y … +4 more , Li X, Wang G, Zhang T, Zhao Y
Biomark Insights · 2025 · PMID 39957864 · Full text
BACKGROUND: Immune checkpoint inhibitors (ICIs) hold a great promise in treatment of non-small cell lung cancer (NSCLC), while only a portion of patients benefited from the treatment, and others could not achieve optimal...
BACKGROUND: Immune checkpoint inhibitors (ICIs) hold a great promise in treatment of non-small cell lung cancer (NSCLC), while only a portion of patients benefited from the treatment, and others could not achieve optimal therapeutic effects from initial immunotherapy, even for those patients with PD-L1 (Programed cell death ligand 1) tested positive. However, the clinical markers for the selection of patients who will benefit from ICIs combination treatment beforehand are largely unknown. OBJECTIVES: The purpose of this study was to explore the non-invasive biomarkers that can predict the efficacy of immune combination therapy in advanced/metastatic NSCLC patients. DESIGN: This study employed a retrospective cohort design to analyze dual predictive biomarkers in advanced non-small cell lung cancer (NSCLC) patients with immune combination therapy. METHOD: An analysis was conducted on baseline information of 144 patients with advanced/metastatic NSCLC who received ICIs treatment from the November of 2018 to the January of 2023 in Beijing Chest Hospital. We established a scoring group chart to make quantitative prediction for overall survival (OS) and progression-free survival (PFS) based on 4 variables, and set up the nomogram model as well as Decision curve analysis (DCA) to assess clinical benefits of ICIs combination in treatment of patients with advanced/metastatic NSCLC. RESULTS: We found that serum globulin (GLB) >26.6 (g/L) (HR = 1.865, = .002), absolute neutrophil counts (ANC) (10/L) > 5 (HR = 2.146, < .001), and bone metastasis (HR = 2.148, < .001) were independent factors affecting the PFS of NSCLC patients. GLB > 26.6 (g/L) (HR = 1.741, = .018), ANC (10/L) >5 (HR = 1.807, = .008), bone metastasis (HR = 1.651, = .002), and PD-L1 Negative (HR = 2.432, = .032) were independent factors affecting the OS of NSCLC patients. Same variables and cut-off value have good predictive efficacy in both PFS and OS. CONCLUSION: In patients with advanced/metastatic NSCLC receiving ICIs combination treatment, the GLB, ANC, bone metastasis, and PD-L1 may serve as useful predictive markers for the prognosis of NSCLC patients with ICIs combination treatment.
Corrigendum to "Comparative Analysis of Biomarkers in Type 2 Diabetes Patients With and Without Comorbidities: Insights Into the Role of Hypertension and Cardiovascular Disease".
Biomark Insights · 2025 · PMID 39935846 · Full text
[This corrects the article DOI: 10.1177/11772719231222111.].
[This corrects the article DOI: 10.1177/11772719231222111.].
The Prognostic Significance of TRs in Hepatocellular Carcinoma: Insights from TCGA and GEO Databases.
Zhou H, Wang W, Liang R … +4 more , Zhu R, Cao J, Sun C, Sun Y
Biomark Insights · 2025 · PMID 39866810 · Full text
BACKGROUND: Reduced expression of thyroid hormone receptors (TRs) has been observed in various human malignancies, though its predictive value in hepatocellular carcinoma (HCC) remains uncertain. OBJECTIVE: To explore th...
BACKGROUND: Reduced expression of thyroid hormone receptors (TRs) has been observed in various human malignancies, though its predictive value in hepatocellular carcinoma (HCC) remains uncertain. OBJECTIVE: To explore the predictive value of TRs in patients with hepatocellular carcinoma. DESIGN: The design was bioinformatic analysis combined with experimental study. METHODS: This study utilized Kaplan-Meier analysis of TR expression profiles from The Cancer Genome Atlas (TCGA). Expression levels of TRs in HCC and immune single cells were assessed using datasets from the Gene Expression Omnibus (GEO) and TCGA, analyzed with R software. Cox and logistic regression analyses were also conducted. Functional assays, including wound healing, CCK-8, and Transwell migration assays, were employed to investigate the role of the THRB gene. RESULTS: Kaplan-Meier analysis revealed that low THRB expression was significantly associated with reduced overall survival (OS), 5-year OS and disease-specific survival (DSS) in HCC patients ( < 0.05), while no significant association was found with THRA expression. Both Cox regression and logistic regression identified low THRB expression as an independent risk factor for HCC. THRB expression was significantly downregulated in tumor tissues compared to non-tumorous tissues in 3 GEO datasets and the TCGA profile. Functional assays confirmed that THRB inhibited HCC cell proliferation and migration. Additionally, single-cell RNA sequencing revealed that THRB was primarily expressed in CD16+ monocytes within tumor tissues and was associated with a poor OS rate. CONCLUSION: Reduced THRB expression, but not THRA, was correlated with decreased OS in HCC patients.
Differentiating Latent Tuberculosis from Active Tuberculosis Through Activation Phenotypes and Chemokine Markers HLA-DR, CD38, MCP-1, and RANTES: A Systematic Review and Meta-Analysis.
Kadi C, Ahmadi N, Houdou A … +9 more , Badisy IE, Bouaddi O, Mennane Z, Najimi N, Benlamari M, Boutayeb S, Khalis M, Mtili NE, Seghrouchni F
Biomark Insights · 2025 · PMID 39802700 · Full text
BACKGROUND: Latent TB infection (LTBI) affects one fourth of the global population. Currently, there is an absence of an optimal strategy for distinguishing between active tuberculosis (aTB) and LTBI. While some research...
BACKGROUND: Latent TB infection (LTBI) affects one fourth of the global population. Currently, there is an absence of an optimal strategy for distinguishing between active tuberculosis (aTB) and LTBI. While some researchers have explored cytokines other than interferon-gamma (IFN-γ) as biomarkers, results have shown significant variability in their ability to differentiate between these conditions. This meta-analysis aims to evaluate the performance of activation phenotype and chemokine markers in distinguishing between aTB and LTBI. OBJECTIVES: To assess the diagnostic accuracy of specific biomarkers (HLA-DR IFNγ, CD38 IFNγ, MCP-1, and RANTES) in differentiating aTB from LTBI. DESIGN: This study was conducted in accordance with the PRISMA guidelines for systematic reviews and meta-analyses of diagnostic studies. DATA SOURCES AND METHODS: We conducted a comprehensive search of PubMed, Scopus, Sciences Direct, and Web of Science for primary studies published in English up to 2023. Studies were included if they reported sensitivity, specificity, diagnostic odds ratio (DOR), and area under the curve (AUC) for the biomarkers in question. We calculated pooled diagnostic sensitivity, specificity, DOR, and AUC, and used the summary receiver operating characteristic curve (SROC) to summarize the diagnostic performance of each biomarker. RESULTS: Sixteen studies involving 1696 participants were included in the analysis. Among them, 925 individuals were diagnosed with aTB, while 771 were classified as having LTBI. The specificity, sensitivity, DOR, and AUC for CD38 IFNγ, HLA-DR IFNγ, RANTES, and MCP-1 were (0.97 [95% CI: 0.72-1.00], 0.90 [95% CI: 0.75-0.96], 291.863, and 0.9432), (0.90 [95% CI: 0.70-0.97], 0.83 [95% CI: 0.63-0.94], 41.819, and 0.8598), (0.68 [95% CI: 0.55-0.79], 0.72 [95% CI: 0.56-0.84], 5.733, and 0.7979), and (0.63 [95% CI: 0.54-0.72], 0.63 [95% CI: 0.50-0.75], 2.892, and 0.7290) respectively. CONCLUSION: The findings indicate that CD38 IFNγ and HLA-DR IFNγ demonstrated the highest diagnostic accuracy. Additional prospective research is necessary to identify the optimal combination of biomarkers to enhance diagnostic accuracy in clinical settings. REGISTRATION: This review has been registered on PROSPERO: (CRD42023472091). Available from: https://www.crd.york.ac.uk/prospero/#recordDetails.
Seroprevalence in Rheumatoid Arthritis Patients with Interstitial Lung Disease.
Oka S, Higuchi T, Furukawa H … +12 more , Shimada K, Okamoto A, Fujimori M, Hashimoto A, Komiya A, Saisho K, Yoshikawa N, Katayama M, Matsui T, Fukui N, Migita K, Tohma S
Biomark Insights · 2024 · PMID 39640205 · Full text
BACKGROUND: Rheumatoid arthritis (RA) is complicated with interstitial lung disease (ILD). Gastroesophageal reflux disease is prevented by infection and is a predisposing factor for idiopathic pulmonary fibrosis. Howeve...
BACKGROUND: Rheumatoid arthritis (RA) is complicated with interstitial lung disease (ILD). Gastroesophageal reflux disease is prevented by infection and is a predisposing factor for idiopathic pulmonary fibrosis. However, the prevalence of infection in RA patients with ILD has not been sufficiently investigated. OBJECTIVE: In this study, we analyzed anti- antibodies in RA patients with ILD. DESIGN: Case-control observational study. METHODS: Anti- antibodies were analyzed in the sera of RA patients using a commercially available enzyme-linked immunosorbent assay kit. RESULTS: The positivity of anti- antibodies in RA with ILD ( = 30 [18.0%], = .0227), usual interstitial pneumonia ( = 10 [14.3%], = .0212), and airway disease ( = 30 [18.0%], = .0227) was significantly lower than that of RA without chronic lung disease ( = 78 [27.5%]). The positivity of anti- antibodies was also lower in RA with chronic lung disease ( = 68 [18.2%], = .0059). Multiple logistic regression analyses showed that the presence of anti- antibodies was independently and protectively associated with chronic lung disease in RA. CONCLUSION: The seroprevalence of was lower in RA with ILD. infection prevented ILD in patients with RA by protecting them from gastroesophageal reflux disease.
D-Dimer in Acute Mesenteric Venous Thrombosis: A Prospective Case-Control International Multicenter Study.
Acosta S, Blaser AR, Nuzzo A … +21 more , Soltanzadeh-Naderi Y, Starkopf J, Forbes A, Murruste M, Tamme K, Voomets AL, Koitmäe M, Bala M, Bodnar Z, Casian D, Demetrashvili Z, Biloslavo A, Muñoz-Cruzado VD, Hess B, Kase K, Kirov M, Lindner M, Loudet CI, Damaskos D, Björck M, AMESI Investigators (Collaborators)
Biomark Insights · 2024 · PMID 39600492 · Full text
BACKGROUND: Acute mesenteric venous thrombosis (MVT) is rarely suspected as primary diagnosis in emergency departments and still carries an in-hospital mortality rate of above 20%. OBJECTIVES: The aim of this study was t...
BACKGROUND: Acute mesenteric venous thrombosis (MVT) is rarely suspected as primary diagnosis in emergency departments and still carries an in-hospital mortality rate of above 20%. OBJECTIVES: The aim of this study was to find differences in clinical and laboratory markers between patients with acute MVT and a control group of suspected but confirmed as not having any type of acute mesenteric ischaemia (AMI). DESIGN: Data was retrieved from the AMESI (Acute MESenteric Ischaemia) study. This international, multicenter prospective case-control study from 32 sites collected data on patients with suspected AMI during a 10-month period. METHODS: Independent factors associated with acute MVT were evaluated in a multivariable logistic regression analysis and expressed as odds ratios (OR) with 95% confidence intervals (CI). RESULTS: D-dimer was not significantly higher in MVT (n = 73) compared to non-AMI (n = 287) patients (median 7.0 mg/L vs 4.5 mg/L, = .092). After entering BMI, atherosclerotic disease, history of venous thromboembolism, CRP, and D-dimer as covariates in a multi-variable logistic regression analysis, absence of atherosclerotic disease (OR 0.096, 95% CI 0.011-0.84; = .034) and elevated D-dimer (OR 2.59/one SD increment, 95% CI 1.07-6.28; = .034) were associated with MVT. The discriminative ability of D-dimer for MVT as assessed by area under the curve in the receiver operating characteristics analysis was 0.63 (95% CI 0.49-0.78). CONCLUSION: Elevated D-dimer was associated with MVT, but the discriminative ability of D-dimer was poor. There is an urgent need to find a more accurate plasma biomarker for this condition. TRIAL REGISTRATION: NCT05218863 (registered 19.01.2022).
Procalcitonin Guided Antibiotic Stewardship.
Kiya GT, Asefa ET, Abebe G … +1 more , Mekonnen Z
Biomark Insights · 2024 · PMID 39559409 · Full text
Despite infection and sepsis being a major public health challenge, early detection and timely management are often hindered by several factors. These includes the similarity of clinical presentations between infectious...
Despite infection and sepsis being a major public health challenge, early detection and timely management are often hindered by several factors. These includes the similarity of clinical presentations between infectious and non-infectious conditisons, as well as limitations of current diagnostic methods such as lengthy turnaround times and low sensitivity. Consequently, there is increasing interest in identifying biomarkers that can quickly and accurately differentiate bacterial sepsis from other inflammatory processes, whether infectious or non-infectious. Procalcitonin has emerged as one of the most extensively studied and utilized biomarkers in managing infection and sepsis, especially within the framework of antibiotic stewardship. This review aims to examine the role of Procalcitonin in guiding antibiotic stewardship. It explores the production and release of procalcitonin and its relevance in the context of infection and sepsis. The discussion focus on the clinical and economic impacts of using procalcitonin to guide the initiation and discontinuation of antibiotics in managing these conditions.
Bladder Cancer Treatments in the Age of Personalized Medicine: A Comprehensive Review of Potential Radiosensitivity Biomarkers.
Feghaly C, Challita R, Hadir HB … +6 more , Mobayed T, Bitar TA, Harbi M, Ghorayeb H, El-Hassan R, Bodgi L
Biomark Insights · 2024 · PMID 39512649 · Full text
Bladder cancer is one of the most frequently diagnosed cancers in men. While cystectomy remains the primary treatment, advances in radiotherapy and chemotherapy have highlighted the value of bladder-preserving strategies...
Bladder cancer is one of the most frequently diagnosed cancers in men. While cystectomy remains the primary treatment, advances in radiotherapy and chemotherapy have highlighted the value of bladder-preserving strategies, which can also enhance patients' quality of life. Despise these advances, around 20% of patients may still require salvage cystectomy due to tumor radioresistance. This underscores the need to develop radiosensitivity predictive assays. Radiotherapy acts by inducing DNA damage, primarily through DNA double-strand breaks, which can significantly affect treatment outcomes if left unrepaired. In addition to activating DNA repair pathways, the response to radiation also involves the tumor microenvironment, cell death pathways, immune responses and different types of cell death and proliferation receptors. In recent years, personalized medicine, which tailors treatments to individual patients, has gained increasing attention in cancer care. The development of chemo- and radiosensitivity predictive assays has become a key focus of cancer research. Despite the potential impact of such assays on bladder cancer treatment, there is still no reliable test that can help clinicians and informs patients in choosing the best treatment. This review aims to highlight studies that attempted to characterize bladder cancer radiosensitivity and to discuss the potential biomarkers that could be used to develop bladder cancer radiosensitivity predictive assays.
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