Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Qualitative FIT, quantitative FIT, and testing for new biomarkers.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers: a Multi-center Prospective Observational Cohort Study
Overview
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.
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.
Primary outcome measures
- 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.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Air Force Military Medical University — Xi'an
Identifiers
NCT: NCT07600125 · KY20262030-C-1