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

NCT07600125 | Not Yet Recruiting

• 1 other identifier: KY20262030-C-1
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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 FIT, quantitative 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.

Conditions

Gastric Cancer, Colorectal Cancer

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

Qualitative FIT, quantitative FIT, and testing for new biomarkers DIAGNOSTIC_TEST

Stool samples are collected from participants before endoscopy for qualitative FIT, quantitative FIT, and novel biomarker testing. The results are used to screen for gastrointestinal cancers.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Zheng

CONTACT

+86 198 2975 8242; zhengrong4956@163.com

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 (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)