- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04160832
Prevalence and Spectrum of Cancer Susceptibility Among Patients With Advanced Colorectal Polyps
August 21, 2023 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
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
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 Contact
- Name: Elizabeth Magnan, BA
- Phone Number: 303-724-4466
- Email: elizabeth.magnan@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado Denver
-
Principal Investigator:
- Swati G Patel, MD MS
-
Contact:
- Elizabeth Magnan
- Phone Number: 303-724-4466
- Email: elizabeth.magnan@ucdenver.edu
-
-
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
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 (Estimated)
July 1, 2025
Study Completion (Estimated)
July 1, 2027
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)
August 22, 2023
Last Update Submitted That Met QC Criteria
August 21, 2023
Last Verified
August 1, 2023
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
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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