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NOT YET RECRUITING
NCT07329816

External, Multicentre Validation of a Machine-Learning Model to Predict Colonic Adenoma in Indian Adults

Sponsor: Asian Institute of Gastroenterology, India

View on ClinicalTrials.gov

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.

Official title: External, Multicentre Validation of a Machine-Learning Model to Predict Colonic Adenoma in Indian Adults-A Prospective, Observational, Multicentre Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-02-01

Completion Date

2027-03-30

Last Updated

2026-01-12

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Not Applicable / Observational study

No 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.