Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers
ConditionGastric Cancer, Colorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXijing Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Qualitative Fecal Immunochemical Test (FIT), quantitative (FIT), and testing for new biomarkers
Diagnostic testStool samples are collected from participants before endoscopy for qualitative Fecal Immunochemical Test (FIT), quantitative Fecal Immunochemical Test (FIT), and novel biomarker testing. The results are used to screen for gastrointestinal cancers.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.Sponsors and contacts
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Source ClinicalTrials.gov