Fact CheckerSign in

NCT07600125Recruiting

Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers

Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers: a Multi-center Prospective Observational Cohort Study

Source: ClinicalTrials.gov · Last updated 11 Aug 2026

Brief summary (registry, in English)

This study is a multi-center, observational study. Participants scheduled for gastroscopy and colonoscopy will undergo an epidemiological assessment and provide a stool sample prior to endoscopy for qualitative Fecal Immunochemical Test (FIT), quantitative Fecal Immunochemical Test (FIT), and novel biomarker testing, followed by the endoscopic examination. After completion of the baseline endoscopic screening, all enrolled participants will undergo a 2-year follow-up. The primary endpoints of the study are sensitivity and specificity for the screening of gastrointestinal cancers.The aim of this study is to develop and evaluate the sensitivity and specificity of fecal multi-marker panels for the screening of gastrointestinal cancers.

Status (registry)
Recruiting
Study type
Observational
Enrollment
5000 (estimated)
First submitted
13 May 2026
Start date
10 Aug 2026
Primary completion date
31 Dec 2027
Lead sponsor
Xijing Hospital
NCT number
NCT07600125

What you commit to

  • Study type: Observational
  • Planned participants: 5000
  • From 10 Aug 2026 to the primary completion date, 31 Dec 2027
  • 13 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent severe medical conditions that reduce the benefits of screening, such as severe pulmonary disease, kidney disease, liver disease, cardiovascular and cerebrovascular diseases, and hematological disorders;

Other illness

  • History of any type of gastrointestinal malignancy;

Other

  • Have undergone gastrointestinal endoscopy screening within the past year;
  • Other situations where a physician determines that endoscopic screening poses excessive risk (e.g., hemodynamic instability) or offers no benefit (e.g., short life expectancy);
  • Pregnant or breastfeeding women.

Who the study is looking for

  • Participants must be at least 18 years of age at the time of enrollment;
  • Participants must be scheduled to undergo gastroscopy and colonoscopy;
  • Participants must agree to undergo a two-year follow-up as outlined in the protocol;
  • Participants must be willing to participate and sign an informed consent form.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Dalian Medical University
Coordinator of this site? Confirm its status
DalianChinaRecruiting
Hongxing Hospital of the 13th Division, Xinjiang Production and Construction Corps
Coordinator of this site? Confirm its status
HamiChinaRecruiting
Cao County People's Hospital
Coordinator of this site? Confirm its status
HezeChinaRecruiting
The 960th Hospital of the Joint Support Force of the People's Liberation Army of China
Coordinator of this site? Confirm its status
JinanChinaRecruiting
PetroChina Central Hospital, Hebei
Coordinator of this site? Confirm its status
LangfangChinaRecruiting
Huoqiu County People's Hospital
Coordinator of this site? Confirm its status
Liu‘anChinaRecruiting
QingDao Municipal Hospital
Coordinator of this site? Confirm its status
QingdaoChinaRecruiting
Central Theater Command General Hospital
Coordinator of this site? Confirm its status
WuhanChinaRecruiting
Wuwei Cancer Hospital of Gansu Province
Coordinator of this site? Confirm its status
WuweiChinaRecruiting
Wuxi People's Hospital
Coordinator of this site? Confirm its status
WuxiChinaRecruiting
The First Affiliated Hospital of Air Force Military Medical University
Coordinator of this site? Confirm its status
Xi'anChinaRecruiting
Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
Coordinator of this site? Confirm its status
ZhaoqingChinaRecruiting
Zhaoqing First People's Hospital, Guangdong Province
Coordinator of this site? Confirm its status
ZhaoqingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.