Colorectal CancerNCT05419531
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
An observational study of Colorectal Cancer, run by Inova Health Care Services at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- prospective observational study - screening and follow up colonoscopy
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2022to 22 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Potential participants will be recruited through distribution of a flyer at endurance events, chat rooms, and race invitations.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
About this study
Official title: Measuring the Incidence of Colorectal Cancer in Young Endurance Athletes
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
- Being tested
- prospective observational study - screening and follow up colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prospective observational study - screening and follow up colonoscopyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of young endurance runners' that have adenomatous polyps.
- 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.
Measured: 36 months
Secondary outcomes (2)
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.
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).
Measured: 36 months
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start18 Oct 2022
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Cannon, MD, Principal investigator, Inova Schar Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419531
- Sponsor's protocol ID
- U21-10-4567
- Status last verified
- Dec 2025
- First submitted
- 10 Jun 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siegel RL, Fedewa SA, Anderson WF, Miller KD, Ma J, Rosenberg PS, Jemal A. Colorectal Cancer Incidence Patterns in the United States, 1974-2013. J Natl Cancer Inst. 2017 Aug 1;109(8):djw322. doi: 10.1093/jnci/djw322.
PubMed 28376186Meyer JE, Narang T, Schnoll-Sussman FH, Pochapin MB, Christos PJ, Sherr DL. Increasing incidence of rectal cancer in patients aged younger than 40 years: an analysis of the surveillance, epidemiology, and end results database. Cancer. 2010 Sep 15;116(18):4354-9. doi: 10.1002/cncr.25432.
PubMed 20734460Cong YJ, Gan Y, Sun HL, Deng J, Cao SY, Xu X, Lu ZX. Association of sedentary behaviour with colon and rectal cancer: a meta-analysis of observational studies. Br J Cancer. 2014 Feb 4;110(3):817-26. doi: 10.1038/bjc.2013.709. Epub 2013 Nov 21.
PubMed 24263062Heer M, Repond F, Hany A, Sulser H, Kehl O, Jager K. Acute ischaemic colitis in a female long distance runner. Gut. 1987 Jul;28(7):896-9. doi: 10.1136/gut.28.7.896.
PubMed 3498668Sanchez LD, Tracy JA, Berkoff D, Pedrosa I. Ischemic colitis in marathon runners: a case-based review. J Emerg Med. 2006 Apr;30(3):321-6. doi: 10.1016/j.jemermed.2005.05.021.
PubMed 16677987Casey E, Mistry DJ, MacKnight JM. Training room management of medical conditions: sports gastroenterology. Clin Sports Med. 2005 Jul;24(3):525-40, viii. doi: 10.1016/j.csm.2005.05.002.
PubMed 16004918de Oliveira EP, Burini RC. The impact of physical exercise on the gastrointestinal tract. Curr Opin Clin Nutr Metab Care. 2009 Sep;12(5):533-8. doi: 10.1097/MCO.0b013e32832e6776.
PubMed 19535976Clausen JP. Effect of physical training on cardiovascular adjustments to exercise in man. Physiol Rev. 1977 Oct;57(4):779-815. doi: 10.1152/physrev.1977.57.4.779. No abstract available.
PubMed 333481Kehl O, Jager K, Munch R, Buhler H, Segantini P, Bollinger A, Ammann R. [Mesenterial anemia as a cause of jogging anemia?]. Schweiz Med Wochenschr. 1986 Jul 19;116(29):974-6. German.
PubMed 3764381Porter AM. Do some marathon runners bleed into the gut? Br Med J (Clin Res Ed). 1983 Nov 12;287(6403):1427. doi: 10.1136/bmj.287.6403.1427. No abstract available.
PubMed 6416441Baska RS, Moses FM, Graeber G, Kearney G. Gastrointestinal bleeding during an ultramarathon. Dig Dis Sci. 1990 Feb;35(2):276-9. doi: 10.1007/BF01536777.
PubMed 2302987Blokzijl F, de Ligt J, Jager M, Sasselli V, Roerink S, Sasaki N, Huch M, Boymans S, Kuijk E, Prins P, Nijman IJ, Martincorena I, Mokry M, Wiegerinck CL, Middendorp S, Sato T, Schwank G, Nieuwenhuis EE, Verstegen MM, van der Laan LJ, de Jonge J, IJzermans JN, Vries RG, van de Wetering M, Stratton MR, Clevers H, Cuppen E, van Boxtel R. Tissue-specific mutation accumulation in human adult stem cells during life. Nature. 2016 Oct 13;538(7624):260-264. doi: 10.1038/nature19768. Epub 2016 Oct 3.
PubMed 27698416Tomasetti C, Li L, Vogelstein B. Stem cell divisions, somatic mutations, cancer etiology, and cancer prevention. Science. 2017 Mar 24;355(6331):1330-1334. doi: 10.1126/science.aaf9011.
PubMed 28336671Scott JP, Sale C, Greeves JP, Casey A, Dutton J, Fraser WD. Effect of exercise intensity on the cytokine response to an acute bout of running. Med Sci Sports Exerc. 2011 Dec;43(12):2297-306. doi: 10.1249/MSS.0b013e31822113a9.
PubMed 21552156Nieman DC, Konrad M, Henson DA, Kennerly K, Shanely RA, Wallner-Liebmann SJ. Variance in the acute inflammatory response to prolonged cycling is linked to exercise intensity. J Interferon Cytokine Res. 2012 Jan;32(1):12-7. doi: 10.1089/jir.2011.0038. Epub 2011 Sep 14.
PubMed 21916608
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Incidence of Colorectal Cancer in Young Endurance Athletes
- ClinicalTrials.gov ID
- NCT05419531
- Acronym / sponsor ID
- U21-10-4567
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Potential participants will be recruited through distribution of a flyer at endurance events, chat rooms, and race invitations.
Key inclusion criteria (6 listed)
- Adult males and females 35-50 years of age
- Male and female self-reported endurance athletes, defined by at least one of the following:
- Ability to complete testing in the protocol and make study visits
- Able and willing to consent to protocol
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prospective observational study - screening and follow up colonoscopyInvolves 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. | Other | – |
Primary outcome
The rate of young endurance runners' that have adenomatous polyps.
Time frame: 36 months
1. Estimate the rate of young endurance runners that have adenomatous polyps. 2. Estimate the rate of young endurance runners that have advanced adenoma and colorectal cancer on screening colonoscopies.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 28376186Siegel RL, Fedewa SA, Anderson WF, Miller KD, Ma J, Rosenberg PS, Jemal A. Colorectal Cancer Incidence Patterns in the United States, 1974-2013. J Natl Cancer Inst. 2017 Aug 1;109(8):djw322. doi: 10.1093/jnci/djw322.
- Background: PubMed 20734460Meyer JE, Narang T, Schnoll-Sussman FH, Pochapin MB, Christos PJ, Sherr DL. Increasing incidence of rectal cancer in patients aged younger than 40 years: an analysis of the surveillance, epidemiology, and end results database. Cancer. 2010 Sep 15;116(18):4354-9. doi: 10.1002/cncr.25432.
- Background: PubMed 24263062Cong YJ, Gan Y, Sun HL, Deng J, Cao SY, Xu X, Lu ZX. Association of sedentary behaviour with colon and rectal cancer: a meta-analysis of observational studies. Br J Cancer. 2014 Feb 4;110(3):817-26. doi: 10.1038/bjc.2013.709. Epub 2013 Nov 21.
- Background: PubMed 3498668Heer M, Repond F, Hany A, Sulser H, Kehl O, Jager K. Acute ischaemic colitis in a female long distance runner. Gut. 1987 Jul;28(7):896-9. doi: 10.1136/gut.28.7.896.
- Background: PubMed 16677987Sanchez LD, Tracy JA, Berkoff D, Pedrosa I. Ischemic colitis in marathon runners: a case-based review. J Emerg Med. 2006 Apr;30(3):321-6. doi: 10.1016/j.jemermed.2005.05.021.
- Background: PubMed 16004918Casey E, Mistry DJ, MacKnight JM. Training room management of medical conditions: sports gastroenterology. Clin Sports Med. 2005 Jul;24(3):525-40, viii. doi: 10.1016/j.csm.2005.05.002.
- Background: PubMed 19535976de Oliveira EP, Burini RC. The impact of physical exercise on the gastrointestinal tract. Curr Opin Clin Nutr Metab Care. 2009 Sep;12(5):533-8. doi: 10.1097/MCO.0b013e32832e6776.
- Background: PubMed 333481Clausen JP. Effect of physical training on cardiovascular adjustments to exercise in man. Physiol Rev. 1977 Oct;57(4):779-815. doi: 10.1152/physrev.1977.57.4.779. No abstract available.
- Background: PubMed 3764381Kehl O, Jager K, Munch R, Buhler H, Segantini P, Bollinger A, Ammann R. [Mesenterial anemia as a cause of jogging anemia?]. Schweiz Med Wochenschr. 1986 Jul 19;116(29):974-6. German.
- Background: PubMed 6416441Porter AM. Do some marathon runners bleed into the gut? Br Med J (Clin Res Ed). 1983 Nov 12;287(6403):1427. doi: 10.1136/bmj.287.6403.1427. No abstract available.
- Background: PubMed 2302987Baska RS, Moses FM, Graeber G, Kearney G. Gastrointestinal bleeding during an ultramarathon. Dig Dis Sci. 1990 Feb;35(2):276-9. doi: 10.1007/BF01536777.
- Background: PubMed 27698416Blokzijl F, de Ligt J, Jager M, Sasselli V, Roerink S, Sasaki N, Huch M, Boymans S, Kuijk E, Prins P, Nijman IJ, Martincorena I, Mokry M, Wiegerinck CL, Middendorp S, Sato T, Schwank G, Nieuwenhuis EE, Verstegen MM, van der Laan LJ, de Jonge J, IJzermans JN, Vries RG, van de Wetering M, Stratton MR, Clevers H, Cuppen E, van Boxtel R. Tissue-specific mutation accumulation in human adult stem cells during life. Nature. 2016 Oct 13;538(7624):260-264. doi: 10.1038/nature19768. Epub 2016 Oct 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Cannon, MD principal investigator
Inova Schar Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of young endurance runners' that have adenomatous polyps. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05419531, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.