Predicting Risk for Post-polypectomy Colorectal Cancer (PREDICT)
Primary Purpose
Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Logistic regression risk model
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
- Kaiser Permanente Northern California Division of Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Use of risk prediction scores
Arm Description
The prediction model is being used to identify patients who are at highest risk for colorectal cancer based on their risk scores.
Outcomes
Primary Outcome Measures
Rates of colorectal neoplasia per number of colonoscopies performed
The investigators anticipate observing changed rates of colorectal neoplasia per number of colonoscopies performed on account of prioritizing higher risk patients.
Secondary Outcome Measures
Full Information
NCT ID
NCT05606081
First Posted
October 7, 2022
Last Updated
February 27, 2023
Sponsor
Kaiser Permanente
Collaborators
The Permanente Medical Group
1. Study Identification
Unique Protocol Identification Number
NCT05606081
Brief Title
Predicting Risk for Post-polypectomy Colorectal Cancer
Acronym
PREDICT
Official Title
Predicting Risk for Post-polypectomy Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Alternative method of implementation, study not needed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
The Permanente Medical Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Polyp, Colorectal Adenoma, Neoplasm, Colorectal
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Use of risk prediction scores
Arm Type
Experimental
Arm Description
The prediction model is being used to identify patients who are at highest risk for colorectal cancer based on their risk scores.
Intervention Type
Device
Intervention Name(s)
Logistic regression risk model
Intervention Description
Logistic regression model to assign risk score, plus time overdue and PROMPT risk category
Primary Outcome Measure Information:
Title
Rates of colorectal neoplasia per number of colonoscopies performed
Description
The investigators anticipate observing changed rates of colorectal neoplasia per number of colonoscopies performed on account of prioritizing higher risk patients.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore R Levin, MD
Organizational Affiliation
Kaiser Permanente Northern California, Division of Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Northern California Division of Research
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Predicting Risk for Post-polypectomy Colorectal Cancer
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