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NCT04160832 Clinical Trial

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

Colorectal Neoplasm Clinical Trial

Official title:
Prevalence and Spectrum of Germline Cancer Susceptibility Gene Mutations Among Patients With Advanced Colorectal Polyps

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04160832
Other study ID # 18-2827.cc
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 24, 2019
Est. completion date July 2027

Study information
Verified date August 2023
Source University of Colorado, Denver
Contact Elizabeth Magnan, BA
Phone 303-724-4466
Email elizabeth.magnan@cuanschutz.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date July 2027
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Genetic:
• Multi-Cancer Cancer Panel
Eligible patients will receive genetic testing to determine germline cancer predisposition.

Locations
Country Name City State
United States University of Colorado Denver Aurora Colorado

Sponsors (1)
Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of germline pathogenic/likely pathogenic variants in cancer predisposition genes in patients with advanced colorectal polyps 3 years
Secondary Risk factors for germline pathogenic/likely pathogenic variants in patients with advanced colorectal polyps 3 years
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