Predicting Risk for Post-polypectomy Colorectal Cancer

NCT05606081 | Withdrawn FDA Device

• 1 other identifier: 1547728-4
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Colorectal Polyp; Colorectal Adenoma; Neoplasm, Colorectal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Use of risk prediction scores

EXPERIMENTAL

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

Interventions

Logistic regression risk model DEVICE

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

Use of risk prediction scores

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• The Permanente Medical Group: collaborator

Study Sites (1)

Kaiser Permanente Northern California Division of Research

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Theodore R Levin, MD

  Kaiser Permanente Northern California, Division of Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: October 7, 2022
• First Posted: November 4, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 31, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

US (1)