Predicting Risk for Post-polypectomy Colorectal Cancer (PREDICT)

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.

Study Overview

• Status: Withdrawn
• Conditions: Colorectal Cancer; Colorectal Adenoma; Colorectal Polyp; Neoplasm, Colorectal
• Intervention / Treatment: Device: Logistic regression risk model

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Northern California Division of Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Logistic regression risk model; Logistic regression model to assign risk score, plus time overdue and PROMPT risk category

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: The Permanente Medical Group
• Investigators: Principal Investigator: Theodore R Levin, MD, Kaiser Permanente Northern California, Division of Research

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: 1547728-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No