Predicting Risk for Post-polypectomy Colorectal Cancer

Colorectal Cancer Clinical Trial

— PREDICT  

Official title:

Predicting Risk for Post-polypectomy Colorectal Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05606081
• Other study ID #: 1547728-4
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Polyp
• Neoplasm, Colorectal

Intervention

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

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California Division of Research	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	The Permanente Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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