NCT05419531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 18, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

June 10, 2022

Last Update Submit

December 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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.

    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).

    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).

    36 months

Interventions

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.

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Potential participants will be recruited through distribution of a flyer at endurance events, chat rooms, and race invitations.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Related Publications (19)

  • 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.

    PMID: 28376186BACKGROUND
  • Meyer 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.

    PMID: 20734460BACKGROUND
  • Cong 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.

    PMID: 24263062BACKGROUND
  • Heer 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.

    PMID: 3498668BACKGROUND
  • Sanchez 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.

    PMID: 16677987BACKGROUND
  • Casey 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.

    PMID: 16004918BACKGROUND
  • de 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.

    PMID: 19535976BACKGROUND
  • Clausen 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.

    PMID: 333481BACKGROUND
  • Kehl 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.

    PMID: 3764381BACKGROUND
  • Porter 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.

    PMID: 6416441BACKGROUND
  • Baska 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.

    PMID: 2302987BACKGROUND
  • Blokzijl 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.

    PMID: 27698416BACKGROUND
  • Tomasetti 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.

    PMID: 28336671BACKGROUND
  • Scott 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.

    PMID: 21552156BACKGROUND
  • Nieman 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.

    PMID: 21916608BACKGROUND
  • Xu G, Lin W, McAinch AJ, Yan X, Weng X. Identification of Urinary Biomarkers for Exercise-Induced Immunosuppression by iTRAQ Proteomics. Biomed Res Int. 2020 Jan 23;2020:3030793. doi: 10.1155/2020/3030793. eCollection 2020.

    PMID: 32047808BACKGROUND
  • Thomas RJ, Kenfield SA, Jimenez A. Exercise-induced biochemical changes and their potential influence on cancer: a scientific review. Br J Sports Med. 2017 Apr;51(8):640-644. doi: 10.1136/bjsports-2016-096343. Epub 2016 Dec 19.

    PMID: 27993842BACKGROUND
  • 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 available.

    PMID: 31375499BACKGROUND
  • Hemmasi G, Sohrabi M, Zamani F, Ajdarkosh H, Rakhshani N, Khoonsari M, Ameli M, Hatami K. Prevalence of colorectal adenoma in an average-risk population aged 40-50 versus 50-60 years. Eur J Cancer Prev. 2015 Sep;24(5):386-90. doi: 10.1097/CEJ.0000000000000097.

    PMID: 25380192BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Timothy Cannon, MD

    Inova Schar Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 15, 2022

Study Start

October 18, 2022

Primary Completion

October 22, 2025

Study Completion

October 22, 2025

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations