Fecal multi-marker tests to screen for gastric and colorectal cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, multi-center study in adults scheduled for gastroscopy and colonoscopy. Participants provide stool samples before endoscopy for qualitative and quantitative FIT plus novel biomarker testing, then undergo endoscopic examination. After the baseline screening, participants will be followed for two years to assess cancer outcomes. The primary endpoints are the sensitivity and specificity of the fecal multi-marker panels for detecting gastrointestinal cancers, with the aim of improving screening accuracy. The study will analyze how the combination of FIT results and new biomarkers perform in identifying cancers in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Air Force Military Medical University
  Xi'an, Shaanxi, China Recruiting
• The First Affiliated Hospital of Dalian Medical University
  Dalian, China Recruiting
• Hongxing Hospital of the 13th Division, Xinjiang Production and Construction Corps
  Hami, China Recruiting
• Cao County People's Hospital
  Heze, China Recruiting
• The 960th Hospital of the Joint Support Force of the People's Liberation Army of China
  Jinan, China Recruiting
• PetroChina Central Hospital, Hebei
  Langfang, China Recruiting

Study contacts

• Study coordinator: Zheng
• Email: zhengrong4956@163.com
• Phone: +86 198 2975 8242

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.