Predicting Risk for Post-polypectomy Colorectal Cancer
NCT05606081 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2023-02-28
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.
Conditions
- Colorectal Cancer
- Colorectal Polyp
- Colorectal Adenoma
- Neoplasm, Colorectal
Interventions
- DEVICE
-
Logistic regression risk model
Logistic regression model to assign risk score, plus time overdue and PROMPT risk category
Sponsors & Collaborators
-
The Permanente Medical Group
collaborator UNKNOWN -
Kaiser Permanente
lead OTHER
Principal Investigators
-
Theodore R Levin, MD · Kaiser Permanente Northern California, Division of Research
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-09-01
- Primary Completion
- 2023-09-01
- Completion
- 2023-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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