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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult males and females 35-50 years of age
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Male and female self-reported endurance athletes, defined by at least one of the following:
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Run at least two races of 50 miles or more
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Run 5 races of 26.2 miles or more
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Ability to complete testing in the protocol and make study visits
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Able and willing to consent to protocol
Exclusion Criteria:
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Known or suspected history of inflammatory bowel disease, familial adenomatous polyposis (FAP), or Lynch Syndrome
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Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants.
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Anticipated poor compliance
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Prisoners or subjects who are involuntarily incarcerated
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Persons with decisional incapacity/cognitive impairment
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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
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Subject is involved with a worker's compensation, personal injury, or other legal matters related to their health
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Subject is enrolled in a separate interventional clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inova Schar Cancer Institute | Fairfax | Virginia | United States | 22031 |
Sponsors and Collaborators
- Inova Health Care Services
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
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- U21-10-4567