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Completed

NCT Number: 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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prospective observational study - screening and follow up colonoscopy

Other

Involves two visits and a colonoscopy. The first visit will be prior to the colonoscopy. 4-35 days after the colonoscopy, there will be a one time appointment to go over the results of the colonoscopy.

Primary outcomes

  1. The rate of young endurance runners' that have adenomatous polyps.

    Time frame: 36 months

    • Estimate the rate of young endurance runners that have adenomatous polyps.
    • Estimate the rate of young endurance runners that have advanced adenoma and colorectal cancer on screening colonoscopies.

Secondary outcomes

  1. Comparison of the rate of young endurance athletes that have adenomatous polyps with that of the historical controls (those in the average risk group).

    Time frame: 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.

    2.3 Secondary Objectives

    • Compare the rate of young endurance runners that have adenomatous polyps with that of the historical controls (those in the average risk group)
    • Compare the rate of young endurance runners that have advanced adenoma and colorectal cancer on screening colonoscopies with that of the historical controls (those in the average risk group).

  2. 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).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Registry information

Official study title

Measuring the Incidence of Colorectal Cancer in Young Endurance Athletes

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2022
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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