CClinicalTrials.gg
WithdrawnNCT05606081PREDICTUpdated Feb 28, 2023

Predicting Risk for Post-polypectomy Colorectal Cancer

An interventional study of Logistic regression risk model in Colorectal Cancer, Colorectal Polyp and Colorectal Adenoma, sponsored by Kaiser Permanente. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-28.

Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research

Why this study was withdrawn
Alternative method of implementation, study not needed
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Cancer
  • Colorectal Polyp
  • Colorectal Adenoma
  • Neoplasm, Colorectal
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

Browse Colorectal Neoplasms studies →

Lead sponsor

Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • DeviceLogistic regression risk model

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

06

What researchers measure

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.

    Time frame: 1 year

07

Study locations

1 site
  • Kaiser Permanente Northern California Division of Research
    Oakland, California 94612, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05606081
Lead sponsor
Kaiser Permanente
Collaborators
The Permanente Medical Group
Responsible party
Sponsor
First posted
Nov 4, 2022
Start date
Sep 1, 2022
Primary completion
Sep 1, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Feb 28, 2023

Study contacts

Theodore R Levin, MD
principal investigator · Kaiser Permanente Northern California, Division of Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion