About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
• 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.
Trial population
1000
Trial design
Cohort
Prospective
Treatments tested in this trial
Not Applicable / Observational study
Procedure/SurgeryNo study-specific intervention is administered. Participants undergo standard-of-care diagnostic colonoscopy and histopathological evaluation. A locked machine-learning model is applied to routinely collected baseline clinical and demographic data for risk prediction only, without influencing clinical management.
Treatment groups
Trial outcomes
Primary outcomes
Area Under the Receiver Operating Characteristic Curve (AUROC) of the Machine Learning Model
Area under the receiver operating characteristic curve (AUROC) of the machine learning-based prediction model for identifying the presence of histologically proven colonic adenoma
Secondary outcomes
Validation Performance of the Machine Learning Prediction Model
Validation performance of the machine learning model for predicting colonic adenoma, assessed using AUROC, calibration metrics (Brier score), and calibration plots in an independent validation cohort.
Locations
Sponsors and contacts
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