Biomarkers in medicine最新文献

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Prognostic value of inflammatory-nutritional indexes and HALP score in advanced stage NSCLC treated with first-line TKI. 炎症营养指标和HALP评分在一线TKI治疗晚期NSCLC中的预后价值。
IF 2.1 4区 医学
Biomarkers in medicine Pub Date : 2025-09-01 Epub Date: 2025-09-13 DOI: 10.1080/17520363.2025.2560797
Ali Ogul, Ali Alper Solmaz, Ilhan Birsenogul, Yunus Coskun, Mahmut Bakır Koyuncu, Abdullah Evren Yetisir, Mahmut Buyuksimsek, Mert Tohumcuoglu, Mehmet Turker, Mustafa Gurbuz, Berna Bozkurt Duman, Timucin Cil
{"title":"Prognostic value of inflammatory-nutritional indexes and HALP score in advanced stage NSCLC treated with first-line TKI.","authors":"Ali Ogul, Ali Alper Solmaz, Ilhan Birsenogul, Yunus Coskun, Mahmut Bakır Koyuncu, Abdullah Evren Yetisir, Mahmut Buyuksimsek, Mert Tohumcuoglu, Mehmet Turker, Mustafa Gurbuz, Berna Bozkurt Duman, Timucin Cil","doi":"10.1080/17520363.2025.2560797","DOIUrl":"10.1080/17520363.2025.2560797","url":null,"abstract":"<p><strong>Aim: </strong>In metastatic Non-small cell lung cancer (NSCLC) with driver mutations, resistance mechanisms may limit treatment benefit, and their detection is expensive. The aim of this retrospective study was to investigate the usability of inflammatory-nutritional indices and hemoglobin, albumin, lymphocyte and platelet (HALP) scores for predicting survival in patients with metastatic NSCLCs with driver mutations undergoing first-line treatment with tyrosine kinase inhibitors (TKIs).</p><p><strong>Patients & methods: </strong>Ninety-two patients using TKIs for metastatic disease with driver mutations were followed up in our center from December 2018 to May 2024. We retrospectively investigated the effects on progression-free survival (PFS) and overall survival (OS) by calculating inflammatory-nutritional indices and HALP scores using pre-treatment laboratory values.</p><p><strong>Results: </strong>Higher plate-let-to-lymphocyte ratios (PLRs) were associated with shorter PFS, whereas a higher prognostic nutritional index (PNI) predicted longer PFS. Similarly, high HALP and PNI scores were significantly associated with longer OS, while lower platelet-to-lymphocyte ratio (PLR), systemic immune inflammatory index (SII) and systemic inflammation response index (SIRI) were linked to improved OS. Multivariate analysis identified only SII as an independent OS prognostic factor (OR = 7.182, <i>p</i> = 0.003).</p><p><strong>Conclusions: </strong>HALP score, PLR, SII, PNI and SIRI may serve as potential prognostic biomarkers in NSCLC patients with driver mutations treated with first-line TKIs.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"847-855"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477862/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145051785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Potentialities and challenges of liquid biopsy in clinical cancer management. 液体活检在临床癌症治疗中的潜力和挑战。
IF 2.1 4区 医学
Biomarkers in medicine Pub Date : 2025-09-01 Epub Date: 2025-10-06 DOI: 10.1080/17520363.2025.2564057
Negin Ghiyasimoghaddam, Navidreza Shayan, Nima Ameli, Mohammadhasan Baghbani, Hanieh Alsadat Mirkatuli, Amir Attaran Khorasani, Nooshin Mohtasham
{"title":"Potentialities and challenges of liquid biopsy in clinical cancer management.","authors":"Negin Ghiyasimoghaddam, Navidreza Shayan, Nima Ameli, Mohammadhasan Baghbani, Hanieh Alsadat Mirkatuli, Amir Attaran Khorasani, Nooshin Mohtasham","doi":"10.1080/17520363.2025.2564057","DOIUrl":"10.1080/17520363.2025.2564057","url":null,"abstract":"<p><p>Assessment of biomarkers through liquid biopsy, accompanied by low invasiveness, provides a more comprehensive analysis of the genetic profile of tumors, a deeper understanding of cancer mechanisms, the capacity for repeated testing over time, a short processing time, ease of obtaining, and economic benefits, making it easier to monitor diseases compared to tissue biopsy. Circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), exosomes, non-coding RNAs, and metabolites provide precise and timely strategies for managing cancer patients. The main challenges are the low concentration of analytes isolated from liquid biopsies, the development of assays with both high sensitivity and specificity, and the lack of clear and comprehensive guidelines for assays, which further complicate the standardization process. Combined detection, including both CTCs and ctDNA assessment in circular bodies, provides valuable information at different stages of the tumor, despite the heterogeneity of tumor cells, for prognosis, dynamic monitoring, and mutation detection. In addition, the combination of biofluid biomarkers and artificial intelligence can enhance the accuracy and efficiency of liquid biopsy, improve real-time monitoring of tumor procedures and treatment responses, and provide precision medicine. This review examines the challenges in standardizing biofluid assays and explores potential solutions to achieve more consistent clinical outcomes.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"895-908"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12542594/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238174","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Commentary: plasma-derived circALG8 and circCAMTA1 as a panel for early diagnosis of non-small cell lung cancer. 评论:血浆来源的circALG8和circCAMTA1可作为非小细胞肺癌早期诊断的一个指标。
IF 2.1 4区 医学
Biomarkers in medicine Pub Date : 2025-09-01 Epub Date: 2025-10-10 DOI: 10.1080/17520363.2025.2573580
Guo-Ming Zhang
{"title":"Commentary: plasma-derived circALG8 and circCAMTA1 as a panel for early diagnosis of non-small cell lung cancer.","authors":"Guo-Ming Zhang","doi":"10.1080/17520363.2025.2573580","DOIUrl":"10.1080/17520363.2025.2573580","url":null,"abstract":"","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"875"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12542608/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145257479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The systemic inflammatory response index (SIRI) as a prognostic factor for long-term survival in patients with pancreatic cancer. 系统性炎症反应指数(SIRI)作为胰腺癌患者长期生存的预后因素。
IF 2.1 4区 医学
Biomarkers in medicine Pub Date : 2025-09-01 Epub Date: 2025-10-11 DOI: 10.1080/17520363.2025.2571395
Ramazan Yolaçan, Ramazan Dertli, Feyzullah Uçmak
{"title":"The systemic inflammatory response index (SIRI) as a prognostic factor for long-term survival in patients with pancreatic cancer.","authors":"Ramazan Yolaçan, Ramazan Dertli, Feyzullah Uçmak","doi":"10.1080/17520363.2025.2571395","DOIUrl":"10.1080/17520363.2025.2571395","url":null,"abstract":"<p><strong>Aims: </strong>Pancreatic cancer has a very poor prognosis and is a leading cause of cancer-related deaths. Our aim is to investigate the presence of novel prognostic markers in pancreatic cancer that are easy to calculate, inexpensive, non-invasive, and do not cause a loss of time.</p><p><strong>Methods: </strong>A total of 164 patients were included in the study. The demographic and clinical characteristics, laboratory findings, and radiological data of the patients were retrospectively reviewed using hospital records.</p><p><strong>Results: </strong>Of the patients, 112 (68.3%) were male, and the mean age of all patients was 63.29 ± 12.5 years. The one-,two-,and five-year survival rates of the patients were determined to be 43.9% (<i>n</i> = 72), 29.3% (<i>n</i> = 48), and 21.3% (<i>n</i> = 35), respectively. During the 1-,2, and 5-year follow-ups, the absence of surgery, advanced disease stage, and elevated systemic inflammation response index (SIRI) were identified as independent risk factors for increased mortality in pancreatic cancer. SIRI was found to be a prognostic factor influencing both short- and long-term survival in pancreatic cancer.</p><p><strong>Conclusion: </strong>We found that SIRI is a stronger prognostic factor than the NLR, PIV, and SII indices in predicting survival in pancreatic cancer. Monitoring SIRI in pancreatic cancer may provide insight into the status of the local immune response and systemic inflammation, and help in estimating patient survival.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"885-893"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12542602/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145273757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Triglyceride-glucose index as a novel biomarker for mild cognitive impairment in patients with coronary artery disease. 甘油三酯-葡萄糖指数作为冠状动脉疾病患者轻度认知障碍的新生物标志物
IF 2.1 4区 医学
Biomarkers in medicine Pub Date : 2025-09-01 Epub Date: 2025-10-10 DOI: 10.1080/17520363.2025.2570634
Lanxin Feng, Jianan Li, Xin Zhao, Jianqiao Song, Shuwen Yang, Xiaoyi Wang, Chenyang Liu, Min Zhang, Chenchen Tu, Xiantao Song
{"title":"Triglyceride-glucose index as a novel biomarker for mild cognitive impairment in patients with coronary artery disease.","authors":"Lanxin Feng, Jianan Li, Xin Zhao, Jianqiao Song, Shuwen Yang, Xiaoyi Wang, Chenyang Liu, Min Zhang, Chenchen Tu, Xiantao Song","doi":"10.1080/17520363.2025.2570634","DOIUrl":"10.1080/17520363.2025.2570634","url":null,"abstract":"<p><strong>Background: </strong>Patients with coronary artery disease (CAD) are at an increased risk of cognitive impairment, yet reliable noninvasive biomarkers for identifying high-risk individuals in this population remain scarce. This study aimed to investigate the association between the triglyceride-glucose (TyG) index and cognitive function in patients with CAD.</p><p><strong>Methods: </strong>This study included 1163 patients with CAD who underwent cognitive function assessment. Multiple regression analyses were conducted to evaluate the relationship between the TyG index and cognitive function. Furthermore, receiver operating characteristic (ROC) curve analysis was conducted to determine the discriminatory ability of the TyG index in identifying patients with mild cognitive impairment (MCI).</p><p><strong>Results: </strong>The TyG index was negatively correlated with Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) scores (<i>r</i> = -0.16, <i>p</i> < 0.001 and <i>r</i> = -0.33, <i>p</i> < 0.001, respectively). Specifically, when the TyG index was ≥8.72, higher values were associated with increased risk of MCI (OR: 3.69, 95% CI: 2.12, 6.58). ROC analysis revealed that the optimal cutoff value for the TyG index was 8.906 (specificity: 73.8%, sensitivity: 60.2%).</p><p><strong>Conclusion: </strong>The TyG index is independently associated with cognitive function in patients with CAD, with elevated values associated with an increased risk of MCI.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"877-884"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12542614/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145273783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Expression and significance of TNFSF12/TWEAK, CD163 in monocytes of patients with newly diagnosed rheumatoid arthritis. 新诊断类风湿性关节炎患者单核细胞中TNFSF12/TWEAK、CD163的表达及意义
IF 2.1 4区 医学
Biomarkers in medicine Pub Date : 2025-09-01 Epub Date: 2025-09-18 DOI: 10.1080/17520363.2025.2562556
Tingting Zeng, Lulu Zeng, Qianbin Dai, Yao Zhou, Qing Luo, Lu Zhang
{"title":"Expression and significance of <i>TNFSF12/</i>TWEAK, <i>CD163</i> in monocytes of patients with newly diagnosed rheumatoid arthritis.","authors":"Tingting Zeng, Lulu Zeng, Qianbin Dai, Yao Zhou, Qing Luo, Lu Zhang","doi":"10.1080/17520363.2025.2562556","DOIUrl":"10.1080/17520363.2025.2562556","url":null,"abstract":"<p><strong>Aim: </strong>A retrospective study was designed to compare the expression levels of TNF superfamily member 12 (TNFSF12), which encodes the protein TNF-like weak inducer of apoptosis (TWEAK), and CD163 in peripheral blood monocytes between rheumatoid arthritis (RA) patients and controls, and to correlate their expression with clinical parameters to investigate their potential association with RA.</p><p><strong>Materials & methods: </strong>RT-qPCR method was used to determine gene expression of TNFSF12 and CD163 in patients with RA, ankylosing spondylitis (AS) and healthy controls (HC). ROC curve, Pearson correlation analysis, and western blot were used to access the diagnostic performance of TNFSF12/TWEAK and CD163, analyze their correlation with other clinical parameters in RA, and evaluate the protein expression of TWEAK and CD163 in RA.</p><p><strong>Results: </strong>TNFSF12 and CD163 in RA patients were higher expressed compared with AS and HC; they were helpful to identify RA patients from controls, with area under ROC curve (AUC) being 0.813 and 0.826, respectively, and correlated with ESR and CRP. TWEAK and CD163 in monocytes from RA were significantly upregulated compared with controls.</p><p><strong>Conclusion: </strong>TNFSF12 and CD163 gene higher expressed in RA patients and related with therapeutic response and inflammation status, can be used as reference index for RA diagnosis and disease monitoring.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"857-865"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477863/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145079690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Neutrophil percentage-to-albumin ratio as a predictor of In-hospital mortality in infective endocarditis. 中性粒细胞百分比-白蛋白比作为感染性心内膜炎住院死亡率的预测因子。
IF 2.1 4区 医学
Biomarkers in medicine Pub Date : 2025-09-01 Epub Date: 2025-09-19 DOI: 10.1080/17520363.2025.2562554
Muhammet Mucahit Tiryaki, Cemalettin Yilmaz, Huseyin Sefa Ince, Banu Karaca, Fatma Kayaalti Esin, Tuncay Kiris
{"title":"Neutrophil percentage-to-albumin ratio as a predictor of In-hospital mortality in infective endocarditis.","authors":"Muhammet Mucahit Tiryaki, Cemalettin Yilmaz, Huseyin Sefa Ince, Banu Karaca, Fatma Kayaalti Esin, Tuncay Kiris","doi":"10.1080/17520363.2025.2562554","DOIUrl":"10.1080/17520363.2025.2562554","url":null,"abstract":"<p><strong>Background: </strong>Infective endocarditis (IE) remains a life-threatening condition despite treatment advances. Early identification of high-risk patients is essential. The neutrophil percentage-to-albumin ratio (NPAR) is a novel inflammatory marker linked to poor outcomes in various diseases, but its prognostic value in IE remains unclear. This study aimed to investigate the association between NPAR and in-hospital mortality in patients with IE.</p><p><strong>Methods: </strong>We retrospectively analyzed 263 patients diagnosed with IE between January 2009 and January 2024 at a tertiary care center. Clinical, laboratory, and echocardiographic data were collected. NPAR was calculated as (Neutrophil %/Albumin [g/dL]). Predictors of mortality were identified using LASSO-based logistic regression, and a nomogram was constructed to illustrate predictive performance.</p><p><strong>Results: </strong>In-hospital mortality occurred in 59 patients (22.4%). NPAR was significantly higher among non-survivors (median: 0.335 vs. 0.228, <i>p</i> < 0.001). High NPAR ( >0.274) was independently associated with in-hospital mortality (OR: 6.70, 95% CI: 3.07-15.61, <i>p</i> < 0.001), along with large vegetation and diabetes mellitus. High NPAR showed good discriminative power (AUC = 0.72, 95% CI: 0.66-0.79, <i>p</i> < 0.001).</p><p><strong>Conclusion: </strong>High NPAR was an independent predictor of in-hospital mortality in IE and may serve as a simple, cost-effective biomarker for early risk stratification.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"867-874"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477859/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145085148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evidence-based medical evidence: non-coding RNAs serve as prognostic biomarkers for gastric cancer. 循证医学证据:非编码rna可作为胃癌预后的生物标志物。
IF 2.1 4区 医学
Biomarkers in medicine Pub Date : 2025-09-01 Epub Date: 2025-10-09 DOI: 10.1080/17520363.2025.2570639
Zhiren Zhou, Hongkun Ma, Yanan Liu, Xueqing Zhang, Xiaojing Huang, Zheng Li, Huanyu Ren, Huiru Niu, Hao Liao, Xiaojing Zhang, Hongzhi Pan, Lina Zou, Shengzhong Rong
{"title":"Evidence-based medical evidence: non-coding RNAs serve as prognostic biomarkers for gastric cancer.","authors":"Zhiren Zhou, Hongkun Ma, Yanan Liu, Xueqing Zhang, Xiaojing Huang, Zheng Li, Huanyu Ren, Huiru Niu, Hao Liao, Xiaojing Zhang, Hongzhi Pan, Lina Zou, Shengzhong Rong","doi":"10.1080/17520363.2025.2570639","DOIUrl":"10.1080/17520363.2025.2570639","url":null,"abstract":"<p><strong>Objective: </strong>There are meta-analyses about the correlation between non-coding RNA and the prognosis of gastric cancer, which are focus on a single or a particular type of non-coding RNA. This study aims to verify the correlation between various non-coding RNAs and the prognosis of gastric cancer through meta-analysis.</p><p><strong>Methods: </strong>The studies documenting the association between non-coding RNAs and the prognosis of gastric cancer up until September 2023 were extracted. The outcomes of the univariate and multivariate analyses were combined for each noncoding RNA. Sources of heterogeneity were determined by meta-regression analysis, and publication bias was assessed using the Egger test.</p><p><strong>Results: </strong>Fifty-five studies were included in meta-analysis, of which 40 reported miRNAs and 14 reported lncRNAs. The up-regulation of miR-17-5p, miR-21, miR-214, miR-20a, lnc-CECR7, lnc-SNHG15, lnc-Sox2ot, lnc-ANRIL, lnc-DSCR8, lnc-ZEB1-AS1 and lnc-NEAT1 were associated with an unfavorable OS in gastric cancer. Elevated level of lnc-PVT1 correlated with an adverse DFS in gastric cancer. A diminished expression of miR-133a, miR-141, miR-206, and miR-1236-3p predicted a poor OS of gastric cancer.</p><p><strong>Conclusions: </strong>Various non-coding RNAs are associated with the prognosis of gastric cancer based on new evidence-based medical evidence, which provides a potential value for clinical diagnosis and treatment.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"921-932"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12542616/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145249887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Trends in clinical studies evaluating neurofilament light chain as a biomarker. 评价神经丝轻链作为生物标志物的临床研究趋势。
IF 2.1 4区 医学
Biomarkers in medicine Pub Date : 2025-09-01 Epub Date: 2025-09-16 DOI: 10.1080/17520363.2025.2562546
Sydney Stern, Kristin Jamenis, Sreedharan Sabarinath, Shawna L Weis, Robert Schuck, Michael Pacanowski
{"title":"Trends in clinical studies evaluating neurofilament light chain as a biomarker.","authors":"Sydney Stern, Kristin Jamenis, Sreedharan Sabarinath, Shawna L Weis, Robert Schuck, Michael Pacanowski","doi":"10.1080/17520363.2025.2562546","DOIUrl":"10.1080/17520363.2025.2562546","url":null,"abstract":"<p><strong>Introduction: </strong>The use of biomarkers as surrogate endpoints, supported by strong mechanistic, epidemiologic, and/or clinical data, provides drug development programs with endpoints that predict clinical benefit and may be more sensitive to drug effects than clinical endpoints. Neurofilament light chain (NfL) is a marker of neuroaxonal injury that has emerged as a promising biomarker for neurodegenerative diseases.</p><p><strong>Methods: </strong>We identified Investigational New Drug programs submitted to the U.S. Food and Drug Administration between 2005-2024 that proposed to use NfL as a pharmacodynamic biomarker, biomarker for patient selection or stratification, and/or surrogate endpoint for accelerated approval.</p><p><strong>Results: </strong>A total of 50 programs were identified with most from the last five years. Of the 50 programs, 94% (<i>n</i> = 47) proposed NfL as a pharmacodynamic biomarker, 8% (<i>n</i> = 4) for patient selection, 52% (<i>n</i> = 26) for patient stratification, and 20% (<i>n</i> = 10) as a surrogate endpoint. Of the programs evaluating NfL as a pharmacodynamic biomarker with available data on NfL levels (<i>n</i> = 21), approximately 50% reported NfL changes that correlated with drug exposure.</p><p><strong>Conclusion: </strong>This analysis highlights the important role that NfL plays in clinical trials and identifies future areas of research and study design considerations to strengthen the support of NfL as a biomarker.</p>","PeriodicalId":9182,"journal":{"name":"Biomarkers in medicine","volume":" ","pages":"813-823"},"PeriodicalIF":2.1,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12453014/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145069062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Prognostic impact of Naples prognostic score on long-term mortality in non-ST-elevation myocardial infarction. 那不勒斯预后评分对非st段抬高型心肌梗死长期死亡率的影响。
IF 2.1 4区 医学
Biomarkers in medicine Pub Date : 2025-09-01 Epub Date: 2025-08-15 DOI: 10.1080/17520363.2025.2548759
Berhan Keskin, Aykun Hakgor, Fatih Erkam Olgun, Ahmet Berk Duman, Beytullah Cakal, Seda Tanyeri, Barkın Kultursay, Canan Elif Yildiz, Emir Dervis, Ibrahim Oguz Karaca, Bilal Boztosun
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