NCT07600125 Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers
| NCT ID | NCT07600125 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xijing Hospital |
| Condition | Gastric Cancer, Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2026-08-10 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2026-08-10 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07600125 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Cancer, Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07600125 currently recruiting?
Yes, NCT07600125 is actively recruiting participants. Contact the research team at zhengrong4956@163.com for enrollment information.
Where is the NCT07600125 trial being conducted?
This trial is being conducted at Xi'an, China, Dalian, China, Hami, China, Heze, China and 9 additional locations.
Who is sponsoring the NCT07600125 clinical trial?
NCT07600125 is sponsored by Xijing Hospital. The trial plans to enroll 5,000 participants.
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