ArticleCancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology2015
Improving the quality of biomarker discovery research: the right samples and enough of them.
Article in Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05876676 (Rapid Diagnostic Centre Biomarker Study), which is not on this map. Cited by 37 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Rapid Diagnostic Centre Biomarker Study
Who cites it
37 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- An original study assessing biomarker success rate in breast cancer recurrence biomarker research.BMC medicine · 2024Pooled it
- Identifying MicroRNAs Suitable for Detection of Breast Cancer: A Systematic Review of Discovery Phases Studies on MicroRNA Expression Profiles.International journal of molecular sciences · 2023Pooled it
- Biomarkers of Chronic Pancreatitis: A systematic literature review.Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.] · 2021Pooled it
- Prognostic DNA methylation markers for sporadic colorectal cancer: a systematic review.Clinical epigenetics · 2018Pooled it
- Article
- Design characteristics of studies evaluating the effect of non-surgical periodontal treatment on systemic health outcomes.Journal of periodontology · 2026Review
- Acute Rheumatic Fever Diagnostic Network (ARC Network) clinical recruitment protocol.BMJ open · 2026Article
- Improving a Plasma Biomarker Panel for Early Detection of Pancreatic Ductal Adenocarcinoma with Aminopeptidase N (ANPEP) and Polymeric Immunoglobulin Receptor (PIGR).Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Mass spectrometry-based proteomics of FFPE tissues: progress, limitations, and clinical translation barriers.Clinical proteomics · 2025Review
- The evolution of analytical techniques for multiplex analysis of protein biomarkers.Expert review of proteomics · 2025Review
- Screening for oropharyngeal cancer: the time is now.Expert review of molecular diagnostics · 2025Article
- Exploration of the role of immune cells and cell therapy in hepatocellular carcinoma.Frontiers in immunology · 2025Review
- Multi-pathway blood biomarkers to target and monitor multidimensional prevention of cognitive and functional decline (nested in the IN-TeMPO study framed within the world-wide FINGERS network).Frontiers in aging neuroscience · 2025Article
- Upgrading of Grade Group 1 Prostate Cancer at Prostatectomy: Germline Risk Factors in a Prospective Cohort.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2024Article
- A Scaled Proteomic Discovery Study for Prostate Cancer Diagnostic Markers Using ProteographInternational journal of molecular sciences · 2024Article
- Article
- Diagnostic and Prognostic Biomarkers of Chronic Pancreatitis: A Conceptual Framework Based on the PRoBE Design.Gastroenterology · 2024Article
- Investigation of Uterine Fluid Extracellular Vesicles' Proteomic Profiles Provides Novel Diagnostic Biomarkers of Bovine Endometritis.Biomolecules · 2024Article
- Extracellular Vesicles as Liquid Biopsy Biomarkers across the Cancer Journey: From Early Detection to Recurrence.Clinical chemistry · 2024Review
- MS-Based Proteomics of Body Fluids: The End of the Beginning.Molecular & cellular proteomics : MCP · 2023Article
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
backgroundBiomarker discovery research has yielded few biomarkers that validate for clinical use. A contributing factor may be poor study designs.
methodsThe goal in discovery research is to identify a subset of potentially useful markers from a large set of candidates assayed on case and control samples. We recommend the PRoBE design for selecting samples. We propose sample size calculations that require specifying: (i) a definition for biomarker performance; (ii) the proportion of useful markers the study should identify (Discovery Power); and (iii) the tolerable number of useless markers amongst those identified (False Leads Expected, FLE).
resultsWe apply the methodology to a study of 9,000 candidate biomarkers for risk of colon cancer recurrence where a useful biomarker has positive predictive value ≥ 30%. We find that 40 patients with recurrence and 160 without recurrence suffice to filter out 98% of useless markers (2% FLE) while identifying 95% of useful biomarkers (95% Discovery Power). Alternative methods for sample size calculation required more assumptions.
conclusionsBiomarker discovery research should utilize quality biospecimen repositories and include sample sizes that enable markers meeting prespecified performance characteristics for well-defined clinical applications to be identified. IMPACT: The scientific rigor of discovery research should be improved.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.