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

NCT04160832 | Completed DMC

• 1 other identifier: 18-2827.cc
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasm

Keywords

genetics; polyps; cancer; multi-gene panel

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (1)

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

  3 years

Interventions

Multi-Cancer Cancer Panel GENETIC

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

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Polyps; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Swati Patel, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: October 24, 2019
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)