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OpenTrials
Completed

NCT Number: NCT04160832

Prevalence and Spectrum of Cancer Susceptibility 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.

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Key information

Conditions

Colorectal Neoplasm Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-Cancer Cancer Panel

Genetic

Eligible patients will receive genetic testing to determine germline cancer predisposition.

Primary outcomes

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

    Time frame: 3 years

Secondary outcomes

  1. Risk factors for germline pathogenic/likely pathogenic variants in patients with advanced colorectal polyps

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2019
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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