Predicting Risk for Post-polypectomy Colorectal Cancer

Not Applicable

Withdrawn

• Conditions: Colorectal Polyp; Colorectal Cancer; Colorectal Adenoma; Neoplasm, Colorectal
• Interventions: Device: Logistic regression risk model

• Registration Number: NCT05606081
• Lead Sponsor: Kaiser Permanente

Brief Summary

This originated as an observational study of Kaiser Permanente Northern California (KPNC) patients with a history of adenoma diagnosed by colonoscopy who received a subsequent surveillance colonoscopy between 2014 and 2019. The original goal of the study was to develop a risk prediction model that would help identify patients at highest risk for a diagnosis of advanced neoplasia (colorectal cancer and/or advanced adenoma) at or within 6 months following their surveillance colonoscopy. Candidate predictors of interest included patient demographics, medical history, and details related to the index colonoscopy. The investigators are now at the implementation stage and applying the risk prediction model to patients awaiting surveillance colonoscopy at select KPNC service areas to help identify those at highest risk for colorectal cancer based on their risk scores.

Detailed Description

In the implementation stage, the risk prediction model is being applied to patients who are awaiting surveillance colonoscopy at select KPNC service areas to help identify those at highest risk for colorectal cancer based on their risk scores. The prediction model is being used in 2-3 service area to identify about 60-80 patients per month who are at highest risk for colorectal cancer based on their risk scores. Risk scores represent one of a number of factors being considered for prioritizing patients for colonoscopy.

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28
• Primary Completion: 2023-09-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients are on the current colonoscopy pending list; excluding those who were fecal immunochemical test-positive, screening colonoscopies, had a colonoscopy in last 12 months or on a voluntary "pause" list

• Hereditary colorectal cancer syndrome (e.g. Lynch syndrome)
• Diagnostic, fecal immunochemical test -positive, or screening indication for colonoscopy

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of risk prediction scores	Logistic regression risk model	The prediction model is being used to identify patients who are at highest risk for colorectal cancer based on their risk scores.

Primary Outcome Measures

Name	Time	Method
Rates of colorectal neoplasia per number of colonoscopies performed	1 year	The investigators anticipate observing changed rates of colorectal neoplasia per number of colonoscopies performed on account of prioritizing higher risk patients.

Trial Locations

Locations (1)

Kaiser Permanente Northern California Division of Research; 🇺🇸 Oakland, California, United States