Clinical trial NCT05606081: Predicting Risk for Post-polypectomy Colorectal Cancer
Official title: Predicting Risk for Post-polypectomy Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Cancer
Colorectal Polyp
Colorectal Adenoma
Neoplasm, Colorectal
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: The Permanente Medical Group
First posted: 2022-11-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Rates of colorectal neoplasia per number of colonoscopies performed
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California Division of Research
state: California
Study officials:
affiliation: Kaiser Permanente Northern California, Division of Research
name: Theodore R Levin, MD
role: PRINCIPAL_INVESTIGATOR
References: