The Purpose of This Study is to Determine the Frequency of Colorectal Cancer in Male and Female Endurance Athletes Between the Ages of 35 and 50
- Conditions
- Colorectal Cancer
- Registration Number
- NCT05419531
- Lead Sponsor
- Inova Health Care Services
- Brief Summary
The purpose of this study is to determine the frequency of colorectal cancer in male and female endurance athletes between the ages of 35 and 50.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
-
Adult males and females 35-50 years of age
-
Male and female self-reported endurance athletes, defined by at least one of the following:
- Run at least two races of 50 miles or more
- Run 5 races of 26.2 miles or more
-
Ability to complete testing in the protocol and make study visits
-
Able and willing to consent to protocol
- Known or suspected history of inflammatory bowel disease, familial adenomatous polyposis (FAP), or Lynch Syndrome
- Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.
- Anticipated poor compliance
- Prisoners or subjects who are involuntarily incarcerated
- Persons with decisional incapacity/cognitive impairment
- Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator unsuitable for the study
- Subject is involved with a worker's compensation, personal injury, or other legal matters related to their health
- Subject is enrolled in a separate interventional clinical trial
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rate of young endurance athletes that have colorectal cancer on screening colonoscopies. 36 months The rate of adenomatous polyps and colorectal cancer will be estimated with their 95% confidence intervals using the exact binomial method
rate of young endurance athletes that have adenomatous polyps 36 months The rate of adenomatous polyps and colorectal cancer will be estimated with their 95% confidence intervals using the exact binomial method
- Secondary Outcome Measures
Name Time Method comparison of the rate of young endurance athletes that have adenomatous polyps with that of the historical controls (those in the average risk group) 36 months Fisher's Exact test will be used to compare the rates of adenomatous polyps and colorectal cancer between the young endurance athletes and that of the historical controls.
Comparison of the rate of young endurance athletes that have colorectal cancer on screening colonoscopies with that of the historical controls (those in the average risk group). 36 months Fisher's Exact test will be used to compare the rates of adenomatous polyps and colorectal cancer between the young endurance athletes and that of the historical controls.
Trial Locations
- Locations (1)
Inova Schar Cancer Institute
🇺🇸Fairfax, Virginia, United States