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Clinical Trials/NCT04160832
NCT04160832
Completed
Not Applicable

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

University of Colorado, Denver1 site in 1 country200 target enrollmentOctober 24, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Neoplasm
Sponsor
University of Colorado, Denver
Enrollment
200
Locations
1
Primary Endpoint
Prevalence of germline pathogenic/likely pathogenic variants in cancer predisposition genes in patients with advanced colorectal polyps
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
October 24, 2019
End Date
August 30, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Prevalence of germline pathogenic/likely pathogenic variants in cancer predisposition genes in patients with advanced colorectal polyps

Time Frame: 3 years

Secondary Outcomes

  • Risk factors for germline pathogenic/likely pathogenic variants in patients with advanced colorectal polyps(3 years)

Study Sites (1)

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