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

Colorectal Cancer Clinical Trial

Official title:

Measuring the Incidence of Colorectal Cancer in Young Endurance Athletes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05419531
• Other study ID #: U21-10-4567
• Status: Recruiting
• Start date: October 18, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: November 2023
• Source: Inova Health Care Services
• Contact: Keary Janet, BS
• Phone: 571-472-0024
• Email: keary.janet[@]inova.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• prospective observational study - screening and follow up colonoscopy
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.

Locations

Country	Name	City	State
United States	Inova Schar Cancer Institute	Fairfax	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

References & Publications (19)

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Steiner P. When suspected 'runner's colitis' in a marathon runner turns out to be cancer-and in the end leads to a new personal best marathon time. Br J Sports Med. 2020 Mar;54(5):311-312. doi: 10.1136/bjsports-2019-100675. Epub 2019 Aug 2. No abstract av — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of young endurance athletes that have adenomatous polyps	The rate of adenomatous polyps and colorectal cancer will be estimated with their 95% confidence intervals using the exact binomial method	36 months
Primary	rate of young endurance athletes that have colorectal cancer on screening colonoscopies.	The rate of adenomatous polyps and colorectal cancer will be estimated with their 95% confidence intervals using the exact binomial method	36 months
Secondary	comparison of the rate of young endurance athletes that have adenomatous polyps with that of the historical controls (those in the average risk group)	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.	36 months
Secondary	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).	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.	36 months