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

ConditionColonoscopy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorAsian Institute of Gastroenterology, India

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Not Applicable / Observational study

    Procedure/Surgery

    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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Single prospective observational cohort1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 YEAR

Secondary outcomes

1

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.

Time frame
1 YEAR

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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