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

NCT07600125 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2026-05-20

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Qualitative FIT, quantitative FIT, and testing for new biomarkers

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.

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07600125 on ClinicalTrials.gov