{"entity":{"id":"paper-gutseer-guide-mol-cancer-2025","kind":"paper","name":"GUIDE: a prospective cohort study for blood-based early detection of gastrointestinal cancers using targeted DNA methylation and fragmentomics sequencing","aka":[],"tldr":"Singlera and Fudan University's GutSeer blood test for five digestive cancers found about eight in ten of them in a blinded test of 846 hospital patients, with about one false positive in eighteen people without cancer.","summary":"Huang and colleagues (Zhongshan Hospital, Fudan University, with Singlera Genomics) designed GutSeer, a targeted bisulphite sequencing panel combining DNA methylation and fragment patterns for five gastrointestinal cancers (colorectal, oesophageal, gastric, liver and pancreatic). It was trained and validated on plasma from 1,057 cancer patients and 1,415 non-cancer controls; in validation the area under the curve was 0.950, with 82.8% sensitivity and 95.8% specificity (colorectal 92.2%, oesophageal 75.5%, gastric 65.3%, liver 92.9%, pancreatic 88.6%). The locked model was then tested blind in 846 inpatients and outpatients at five hospitals, including 198 stage I or II cancers and 63 advanced precancerous lesions: 81.5% sensitivity and 94.4% specificity for gastrointestinal cancers. Registered as NCT05431621.","asOf":"2026-11-03","links":[{"label":"Molecular Cancer 2025: GUIDE (GutSeer)","url":"https://doi.org/10.1186/s12943-025-02367-x"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/40468355/"},{"label":"ClinicalTrials.gov NCT05431621","url":"https://clinicaltrials.gov/study/NCT05431621"}],"tags":[],"related":[],"cancers":["colorectal","esophageal","gastric","hcc","pancreatic"],"sections":["early-detection"],"technologies":["mced","cfdna-methylation-testing","fragmentomics"],"targets":[],"drugs":["gutseer"],"companies":["singlera"],"institutions":["zhongshan-hospital-fudan","city-of-hope"],"pathways":[],"terms":[],"trials":["guide-gutseer"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["molecular-cancer"],"dependsOn":[],"notes":[],"journal":"Molecular Cancer","year":2025,"doi":"10.1186/s12943-025-02367-x","pmid":"40468355","authors":"Huang A, Guo DZ, Su ZX, Zhong YS, et al.","paperType":"observational","findings":["Validation: 82.8% sensitivity, 95.8% specificity; gastric 65.3%, liver 92.9%.","Blinded hospital test cohort of 846: 81.5% sensitivity, 94.4% specificity."],"whatItMeans":"Strong figures in hospital patients, but at about 94 to 96% specificity roughly one in twenty people without cancer would test positive, too many for screening healthy people without a second test.","caveats":["Hospital inpatients and outpatients, not a screening population.","The abstract gives no stage I figure.","Singlera Genomics staff among authors."],"changedPractice":false},"route":"/key-papers/paper-gutseer-guide-mol-cancer-2025/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"hcc","kind":"cancer","name":"Hepatocellular carcinoma","route":"/cancers/hcc/"},{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"section":[{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"cfdna-methylation-testing","kind":"technology","name":"Cell-free DNA methylation tests","route":"/technologies/cfdna-methylation-testing/"},{"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":"gutseer","kind":"drug","name":"GutSeer","route":"/drugs/gutseer/"}],"company":[{"id":"singlera","kind":"company","name":"Singlera Genomics","route":"/companies/singlera/"}],"institution":[{"id":"city-of-hope","kind":"institution","name":"City of Hope","route":"/institutions/city-of-hope/"},{"id":"zhongshan-hospital-fudan","kind":"institution","name":"Zhongshan Hospital, Fudan University","route":"/institutions/zhongshan-hospital-fudan/"}],"trial":[{"id":"guide-gutseer","kind":"trial","name":"GUIDE (molecular models for early diagnosis of digestive cancers, Zhongshan Hospital and Singlera)","route":"/trials/guide-gutseer/"}],"journal":[{"id":"molecular-cancer","kind":"journal","name":"Molecular cancer","route":"/journals/molecular-cancer/"}]}}