{"entity":{"id":"paper-pathfinder-design-cancers-2021","kind":"paper","name":"The PATHFINDER Study: Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test into Clinical Practice","aka":[],"tldr":"The published plan for PATHFINDER, the first study to give Galleri results back to people without symptoms, set out what it would measure and what it expected to find.","summary":"Design paper for PATHFINDER (NCT04241796): about 6,200 participants aged 50 or older with or without additional cancer risk factors would have a targeted methylation cell-free DNA test, with signal-detected participants evaluated at their physician's discretion. The primary objective was the number and types of diagnostic tests needed for diagnostic resolution. From microsimulations the authors expected a median of 106 signal-detected results, 52 cancers and a positive predictive value of 49% (95% CI 39 to 58).","asOf":"2026-10-29","links":[{"label":"Cancers 2021: PATHFINDER design","url":"https://doi.org/10.3390/cancers13143501"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/34298717/"}],"tags":[],"related":["paper-pathfinder-lancet-2023"],"cancers":[],"sections":["early-detection"],"technologies":["mced"],"targets":[],"drugs":["galleri"],"companies":["grail"],"institutions":[],"pathways":[],"terms":["ppv"],"trials":["pathfinder"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["cancers-mdpi"],"dependsOn":[],"notes":[],"journal":"Cancers","year":2021,"doi":"10.3390/cancers13143501","pmid":"34298717","authors":"Nadauld LD, McDonnell CH, Beer TM, et al.","paperType":"methods","findings":["Expected 106 signal-detected results, 52 cancers and positive predictive value 49% by microsimulation.","Primary objective: the diagnostic tests needed to resolve a positive result."],"whatItMeans":"Set beside the result (35 cancers among 92 positives, positive predictive value 38%), it shows the test found fewer cancers than its makers had modelled.","caveats":["Projections, not results.","Sponsored by GRAIL."],"changedPractice":false,"participants":6200},"route":"/key-papers/paper-pathfinder-design-cancers-2021/","neighbours":{"paper":[{"id":"paper-pathfinder-lancet-2023","kind":"paper","name":"PATHFINDER: the first prospective test of a multi-cancer blood test in people without symptoms","route":"/key-papers/paper-pathfinder-lancet-2023/"}],"section":[{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"mced","kind":"technology","name":"Multi-cancer early detection (MCED)","route":"/technologies/mced/"}],"drug":[{"id":"galleri","kind":"drug","name":"Galleri","route":"/drugs/galleri/"}],"company":[{"id":"grail","kind":"company","name":"GRAIL","route":"/companies/grail/"}],"term":[{"id":"ppv","kind":"term","name":"Positive predictive value (PPV)","route":"/terms/ppv/"}],"trial":[{"id":"pathfinder","kind":"trial","name":"PATHFINDER (first prospective study of the Galleri test)","route":"/trials/pathfinder/"}],"journal":[{"id":"cancers-mdpi","kind":"journal","name":"Cancers","route":"/journals/cancers-mdpi/"}]}}