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
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Recruiting |
| Hongxing Hospital of the 13th Division, Xinjiang Production and Construction Corps Coordinator of this site? Confirm its status | Hami | China | Recruiting |
| Cao County People's Hospital Coordinator of this site? Confirm its status | Heze | China | Recruiting |
| The 960th Hospital of the Joint Support Force of the People's Liberation Army of China Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| PetroChina Central Hospital, Hebei Coordinator of this site? Confirm its status | Langfang | China | Recruiting |
| Huoqiu County People's Hospital Coordinator of this site? Confirm its status | Liu‘an | China | Recruiting |
| QingDao Municipal Hospital Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| Central Theater Command General Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Wuwei Cancer Hospital of Gansu Province Coordinator of this site? Confirm its status | Wuwei | China | Recruiting |
| Wuxi People's Hospital Coordinator of this site? Confirm its status | Wuxi | China | Recruiting |
| The First Affiliated Hospital of Air Force Military Medical University Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province Coordinator of this site? Confirm its status | Zhaoqing | China | Recruiting |
| Zhaoqing First People's Hospital, Guangdong Province Coordinator of this site? Confirm its status | Zhaoqing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.