{"entity":{"id":"guide-gutseer","kind":"trial","name":"GUIDE (molecular models for early diagnosis of digestive cancers, Zhongshan Hospital and Singlera)","aka":["GUIDE","GutSeer study"],"tldr":"The Chinese case-control study behind GutSeer, a blood test for several digestive-system cancers developed with Singlera Genomics.","summary":"GUIDE (NCT05431621) is a single-blind, multicentre case-control study sponsored by Shanghai Zhongshan Hospital with Singlera Genomics and four other centres. Its registry purpose is to establish non-invasive tests for oesophageal, gastric and colorectal cancer from circulating tumour DNA methylation, mutations, fragment size and end motifs, and for hepatocellular carcinoma from methylation, low-pass whole-genome sequencing, microRNA and circulating tumour cells, and to evaluate their sensitivity and specificity. The results paper (Huang 2025) reports GutSeer, which covers five digestive cancers including pancreatic.\n\nThe registry record, read on 3 November 2026, gives its status as completed, with 2,430 participants enrolled, a start on 15 November 2020 and primary completion on 30 June 2023.","status":"completed","asOf":"2026-11-03","links":[{"label":"ClinicalTrials.gov NCT05431621","url":"https://clinicaltrials.gov/study/NCT05431621"}],"tags":[],"related":[],"cancers":["esophageal","gastric","colorectal","hcc"],"sections":["early-detection"],"technologies":["mced","liquid-biopsy"],"targets":[],"drugs":["gutseer"],"companies":["singlera"],"institutions":["zhongshan-hospital-fudan"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05431621","phase":"observational","setting":"People with oesophageal, gastric, colorectal or liver cancer, people with precancerous lesions and healthy controls at Shanghai and Hubei hospitals, giving blood to build and blind-test molecular models","sponsor":"Shanghai Zhongshan Hospital with Xuhui Central Hospital, Changhai Hospital, Hubei Cancer Hospital, Shanghai Public Health Clinical Center and Singlera Genomics","started":"2020-11-15","startedType":"actual","yearReported":2025,"enrolled":2430,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/guide-gutseer/","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/"}],"section":[{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"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":"zhongshan-hospital-fudan","kind":"institution","name":"Zhongshan Hospital, Fudan University","route":"/institutions/zhongshan-hospital-fudan/"}],"paper":[{"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","route":"/key-papers/paper-gutseer-guide-mol-cancer-2025/"}]}}