{"entity":{"id":"paper-spot-mas-k-detek-bmc-med-2025","kind":"paper","name":"Prospective validation study: a non-invasive circulating tumor DNA-based assay for simultaneous early detection of multiple cancers in asymptomatic adults","aka":[],"tldr":"In 9,024 Vietnamese adults without symptoms, the SPOT-MAS blood test was positive in about one in two hundred, and four in ten of those had cancer.","summary":"K-DETEK (NCT05227261) enrolled 9,057 asymptomatic adults aged 40 or older at 75 hospitals and one research institute in Vietnam, followed for 12 months. Of 9,024 eligible, 43 (0.48%) tested positive; 17 were confirmed with cancer, 9 matching the predicted tissue of origin: positive predictive value 39.53% (95% CI 26.37 to 54.42), tissue-of-origin accuracy 52.94%. Of 8,981 negatives, 8,974 were cancer-free at 12 months (negative predictive value 99.92%). Sensitivity was 70.83% (50.83 to 85.09) and specificity 99.71% (99.58 to 99.80).","asOf":"2026-10-29","links":[{"label":"BMC Medicine 2025: K-DETEK","url":"https://doi.org/10.1186/s12916-025-03929-y"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/39948555/"},{"label":"ClinicalTrials.gov NCT05227261","url":"https://clinicaltrials.gov/study/NCT05227261"}],"tags":[],"related":[],"cancers":[],"sections":["early-detection"],"technologies":["mced","fragmentomics"],"targets":[],"drugs":["spot-mas"],"companies":["gene-solutions"],"institutions":[],"pathways":[],"terms":["ppv"],"trials":["k-detek"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"BMC Medicine","year":2025,"doi":"10.1186/s12916-025-03929-y","pmid":"39948555","authors":"Nguyen LHD, Nguyen THH, Le VH, et al.","paperType":"observational","findings":["43 of 9,024 positive (0.48%); 17 cancers; positive predictive value 39.5%.","Sensitivity 70.8% (24 cancers in total), specificity 99.71%.","Tissue of origin correct in 9 of 17."],"whatItMeans":"A prospective screening result in a lower-middle-income country, with a positive predictive value similar to PATHFINDER's; the sensitivity rests on 24 cancers, and the test's tissue call was right about half the time.","caveats":["Single-arm; 24 cancers in total, so wide confidence intervals.","No stage I figure in the abstract.","Sponsored by Gene Solutions."],"changedPractice":false,"participants":9057},"route":"/key-papers/paper-spot-mas-k-detek-bmc-med-2025/","neighbours":{"section":[{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"fragmentomics","kind":"technology","name":"cfDNA fragmentomics","route":"/technologies/fragmentomics/"},{"id":"mced","kind":"technology","name":"Multi-cancer early detection (MCED)","route":"/technologies/mced/"}],"drug":[{"id":"spot-mas","kind":"drug","name":"SPOT-MAS","route":"/drugs/spot-mas/"}],"company":[{"id":"gene-solutions","kind":"company","name":"Gene Solutions","route":"/companies/gene-solutions/"}],"term":[{"id":"ppv","kind":"term","name":"Positive predictive value (PPV)","route":"/terms/ppv/"}],"trial":[{"id":"k-detek","kind":"trial","name":"K-DETEK (SPOT-MAS in adults without symptoms, Vietnam)","route":"/trials/k-detek/"}]}}