Predicting Risk for Post-polypectomy Colorectal Cancer

NCT ID: NCT05606081

Last Updated: 2023-02-28

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Colorectal Polyp Colorectal Adenoma Neoplasm, Colorectal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Use of risk prediction scores

The prediction model is being used to identify patients who are at highest risk for colorectal cancer based on their risk scores.

Group Type EXPERIMENTAL

Logistic regression risk model

Intervention Type DEVICE

Logistic regression model to assign risk score, plus time overdue and PROMPT risk category

Interventions

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Logistic regression risk model

Logistic regression model to assign risk score, plus time overdue and PROMPT risk category

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Permanente Medical Group

UNKNOWN

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Theodore R Levin, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente Northern California, Division of Research

Locations

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Kaiser Permanente Northern California Division of Research

Oakland, California, United States

Site Status

Countries

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United States

Other Identifiers

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1547728-4

Identifier Type: -

Identifier Source: org_study_id

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