External, Multicentre Validation of a Machine-Learning Model to Predict Colonic Adenoma in Indian… (NCT07329816) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
External, Multicentre Validation of a Machine-Learning Model to Predict Colonic Adenoma in Indian Adults
1,000 participantsStarted 2026-02-01
Plain-language summary
Colorectal adenomas are precursors to colorectal cancer (CRC). Accurate pre-procedure risk stratification could optimize colonoscopy yield and resource allocation in India, where adenoma prevalence varies by age, sex, and lifestyle/metabolic factors. ML models can integrate multiple predictors to estimate individualized risk.
Existing risk scores are largely Western; performance and calibration may not be appropriate in Indian populations with different socio-demographic and metabolic profiles. External, prospective, multicentre validation is essential before clinical implementation.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults ≥18 years undergoing diagnostic colonoscopy.
* Adequate bowel preparation (Boston Bowel Preparation Scale total ≥6 with each segment ≥2).
* Complete examination (cecal intubation; withdrawal time ≥6 min when no therapy).
* Availability of all model predictors per CRF.
Exclusion Criteria:
* • Known CRC or polyp, prior colectomy, polyposis syndromes, known IBD, or strong hereditary CRC syndromes (e.g., Lynch) if excluded in derivation.
* Inadequate prep, incomplete colonoscopy, obstructing lesions preventing optical diagnosis beyond obstruction.
* Emergency colonoscopies, therapeutic-only procedures without diagnostic intent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under the Receiver Operating Characteristic Curve (AUROC) of the Machine Learning Model