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

August 6, 2026 updated by: Xijing Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Dalian, China
        • Recruiting
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
      • Hami, China
        • Recruiting
        • Hongxing Hospital of the 13th Division, Xinjiang Production and Construction Corps
        • Contact:
      • Heze, China
        • Recruiting
        • Cao County People's Hospital
        • Contact:
      • Jinan, China
        • Recruiting
        • The 960th Hospital of the Joint Support Force of the People's Liberation Army of China
        • Contact:
      • Langfang, China
        • Recruiting
        • PetroChina Central Hospital, Hebei
        • Contact:
      • Liu‘an, China
        • Recruiting
        • Huoqiu County People's Hospital
        • Contact:
      • Qingdao, China
        • Recruiting
        • Qingdao Municipal Hospital
        • Contact:
      • Wuhan, China
        • Recruiting
        • Central Theater Command General Hospital
        • Contact:
      • Wuwei, China
        • Recruiting
        • Wuwei Cancer Hospital of Gansu Province
        • Contact:
      • Wuxi, China
        • Recruiting
        • Wuxi People's Hospital
        • Contact:
      • Zhaoqing, China
        • Recruiting
        • Zhaoqing First People's Hospital, Guangdong Province
        • Contact:
      • Zhaoqing, China
        • Recruiting
        • Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • The First Affiliated Hospital of Air Force Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will enroll individuals aged 18 and older who are scheduled to undergo gastrointestinal endoscopy and are willing to participate in the screening.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Have undergone gastrointestinal endoscopy screening within the past year;
  2. History of any type of gastrointestinal malignancy;
  3. 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;
  4. 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);
  5. Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and Specificity of Stool-Based Biomarker Testing for Gastrointestinal Cancer Screening
Time Frame: At the time of baseline endoscopic screening, approximately 2 weeks after stool sample collection.
At the time of baseline endoscopic screening, approximately 2 weeks after stool sample collection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 10, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20262030-C-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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