Clinical trial NCT05419531: 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
Official title: Measuring the Incidence of Colorectal Cancer in Young Endurance Athletes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants will be recruited through distribution of a flyer at endurance events, chat rooms, and race invitations.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: rate of young endurance athletes that have adenomatous polyps
timeFrame: 36 months
measure: rate of young endurance athletes that have colorectal cancer on screening colonoscopies.
timeFrame: 36 months
Secondary outcomes:
measure: comparison of the rate of young endurance athletes that have adenomatous polyps with that of the historical controls (those in the average risk group)
timeFrame: 36 months
measure: 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).
timeFrame: 36 months
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
Study officials:
affiliation: Inova Schar Cancer Institute
name: Timothy Cannon, MD
role: PRINCIPAL_INVESTIGATOR
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