External, Multicentre Validation of a Machine-Learning Model to Predict Colonic Adenoma in Indian Adults
NCT ID: NCT07329816
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1000 participants
OBSERVATIONAL
2026-02-01
2027-03-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Single prospective observational cohort
Participants undergo standard-of-care colonoscopy
No allocation into treatment or comparison arms
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Inadequate prep, incomplete colonoscopy, obstructing lesions preventing optical diagnosis beyond obstruction.
* Emergency colonoscopies, therapeutic-only procedures without diagnostic intent.
18 Years
75 Years
ALL
No
Sponsors
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Asian Institute of Gastroenterology, India
OTHER
Responsible Party
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Mohan Ramchandani
Consultant Gastroenterology
Central Contacts
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Other Identifiers
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VALID-ADENOMA-IN
Identifier Type: -
Identifier Source: org_study_id
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