Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers
1 other identifier
observational
5,000
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2026
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2026
CompletedFirst Posted
Study publicly available on registry
May 20, 2026
CompletedStudy Start
First participant enrolled
August 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
August 11, 2026
May 1, 2026
1.4 years
May 13, 2026
August 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity of Stool-Based Biomarker Testing for Gastrointestinal Cancer Screening
At the time of baseline endoscopic screening, approximately 2 weeks after stool sample collection.
Interventions
Stool samples are collected from participants before endoscopy for qualitative Fecal Immunochemical Test (FIT), quantitative Fecal Immunochemical Test (FIT), and novel biomarker testing. The results are used to screen for gastrointestinal cancers.
Eligibility Criteria
The study will enroll individuals aged 18 and older who are scheduled to undergo gastrointestinal endoscopy and are willing to participate in the screening.
You may qualify if:
- 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.
You may not qualify if:
- Have undergone gastrointestinal endoscopy screening within the past year;
- History of any type of gastrointestinal malignancy;
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (13)
The First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710032, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
Hongxing Hospital of the 13th Division, Xinjiang Production and Construction Corps
Hami, China
Cao County People's Hospital
Heze, China
The 960th Hospital of the Joint Support Force of the People's Liberation Army of China
Jinan, China
PetroChina Central Hospital, Hebei
Langfang, China
Huoqiu County People's Hospital
Liu‘an, China
Qingdao Municipal Hospital
Qingdao, China
Central Theater Command General Hospital
Wuhan, China
Wuwei Cancer Hospital of Gansu Province
Wuwei, China
Wuxi People's Hospital
Wuxi, China
Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
Zhaoqing, China
Zhaoqing First People's Hospital, Guangdong Province
Zhaoqing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2026
First Posted
May 20, 2026
Study Start
August 10, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
August 11, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
Once the study is complete, submit a request to the principal investigator. The applicant must provide a data analysis plan, and a decision on whether to share the data will be made following an evaluation.