Prevalence and Spectrum of Cancer Susceptibility Among Patients with Advanced Colorectal Polyps

January 13, 2025 updated by: University of Colorado, Denver

Prevalence and Spectrum of Germline Cancer Susceptibility Gene Mutations Among Patients with Advanced Colorectal Polyps

The study is being conducted to determine the prevalence and risk factors for germline cancer susceptibility genetic mutations among patients with advanced colorectal polyps.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Males and females aged 18 - 89, who have been diagnosed with advanced colorectal polyps.

Description

Inclusion Criteria:

  • Provision to sign and date the consent form
  • Stated willingness to comply with all study procedures and be available for the duration of the study
  • Be a male or female aged 18-89
  • Undergone colonoscopy
  • At least one advanced colorectal polyp, defined as having any of the following:
  • Any polyp ≥ 1cm (adenoma or serrated polyp)
  • Any polyp with villous architecture
  • Any polyp with high-grade dysplasia
  • Sessile serrated polyps with any dysplasia
  • Traditional serrated adenoma

Exclusion Criteria:

  • Known hereditary cancer syndrome
  • Personal history of inflammatory bowel disease
  • Personal history of colorectal cancer
  • Polyp histology or size unavailable or not documented

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of germline pathogenic/likely pathogenic variants in cancer predisposition genes in patients with advanced colorectal polyps
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Risk factors for germline pathogenic/likely pathogenic variants in patients with advanced colorectal polyps
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Swati Patel, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2019

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

November 8, 2019

First Submitted That Met QC Criteria

November 8, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-2827.cc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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