ArticleJournal of the National Cancer Institute2023
Study design considerations for trials to evaluate multicancer early detection assays for clinical utility.
Article in Journal of the National Cancer Institute, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07741435 (Evaluation of a Rapid Test for the Detection of Methylation Profiles), which is not on this map. Cited by 34 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Evaluation of a Rapid Test for the Detection of Methylation Profiles (Methylscape) in Various Body Fluids as a Universal Biomarker for Cancer Detection and Monitoring
Who cites it
34 citing papers in PubMed, 50 citations in OpenAlex.
- The Vanguard Study: Assessing feasibility of conducting randomized trials of novel multi-cancer detection tests.Contemporary clinical trials · 2026Article
- Positive predictive value metrics for multicancer detection tests.Journal of medical screening · 2026Article
- Bias in Meta-Analytic Modeling of Surrogate Endpoints in Cancer Screening Trials.Statistics in medicine · 2026Article
- Attention U-Net-Based Segmentation and Hybrid Classification for Detection of Circulating Tumor-Associated Cells.Cancers · 2026Article
- Increasing power and robustness in screening trials by testing stored specimens in the control arm.BMC medical research methodology · 2026Article
- Measuring and defining screening benefit in a new era of cancer early detection.Journal of the National Cancer Institute · 2026Article
- The ethics of multi-cancer screening.Nature medicine · 2026Article
- Advances in NIR-II Fluorescent Nanoprobes: Design Principles, Optical Engineering, and Emerging Translational Directions.Micromachines · 2025Review
- Modeling the Impact of Multicancer Early Detection Tests: A Review of Natural History of Disease Models.Medical decision making : an international journal of the Society for Medical Decision Making · 2025Review
- Framework to Select Multi-Cancer Detection Assays in the National Cancer Institute's Vanguard Study.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2025Article
- Liquid biopsy-based multi-cancer early detection: an exploration road from evidence to implementation.Science bulletin · 2025Review
- The Potential and Limitations of the MinION/Yenos Platform for miRNA-Enabled Early Cancer Detection.International journal of molecular sciences · 2025Article
- Multicancer early detection testing: Guidance for primary care discussions with patients.Cancer · 2025Review
- Copy-number alterations in cell-free DNA can be transient or harbingers of clonal hematopoiesis.NPJ precision oncology · 2025Article
- Multicancer Detection (MCD) Testing in Gastrointestinal Cancers: An Evolving Tool for Early Diagnosis.Current gastroenterology reports · 2025Review
- Testing stored control-arm specimens could dramatically increase statistical power yet reduce costs in cancer screening trials.Journal of the National Cancer Institute · 2025Article
- Design of randomized controlled trials to estimate cancer-mortality reductions from multicancer detection screening.Journal of the National Cancer Institute · 2025Article
- Transforming cancer screening: the potential of multi-cancer early detection (MCED) technologies.International journal of clinical oncology · 2025Review
- Accelerating progress to reduce the cancer burden through prevention and control in the United States.Journal of the National Cancer Institute · 2025Article
- Integrating Multi-Cancer Early Detection (MCED) Tests with Standard Cancer Screening: System Dynamics Model Development and Feasibility Testing.PharmacoEconomics - open · 2025Article
Corrections and comments
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Authors and funding
11 authors at 2 institutions in 1 country.
Funding
Abstract
Blood-based assays using various technologies and biomarkers are in commercial development for the purpose of detecting multiple cancer types concurrently at an early stage of disease. These multicancer early detection (MCED) assays have the potential to improve the detection of cancers, particularly those for which no current screening modality exists. However, the unknown clinical benefits and harms of using MCED assays for cancer screening necessitate the development and implementation of a randomized controlled trial (RCT) to ascertain their clinical effectiveness. This was the consensus of experts at a National Cancer Institute-hosted workshop to discuss initial design concepts for such a trial. Using these assays to screen simultaneously for multiple cancers poses novel uncertainties for patient care compared with conventional screening tests for single cancers, such as establishing the diagnostic workup to confirm the presence of cancer at any organ site; clarifying appropriate follow-up for a positive assay for which there is no definitive diagnosis; identifying potential harms such as overdiagnosis of indolent disease; determining clinically effective and efficient strategies for disseminating MCED screening in real-world practice; and understanding the ethical implications, such as potentially alleviating or exacerbating existing health disparities. These assays present new and complex challenges for designing an RCT. Issues that emerged from the meeting centered around the need for a flexibly designed, clinical utility RCT to rigorously capture the evidence required to fully understand the net benefit of this promising technology. Specific topic areas were endpoints, screening protocols, recruitment, diagnostic pathway, pilot phase, data elements, specimen collection, and ethical considerations.
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Registered trials
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.