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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: prospective observational study - screening and follow up colonoscopy

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Keary Janet, BS; Phone Number: 571-472-0024; Email: keary.janet@inova.org
• Study Contact Backup: Name: Stephanie Van Bebber; Phone Number: 571-472-0213; Email: stephanie.VanBebber@inova.org

Study Locations

• United States
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Inova Schar Cancer Institute
      • Principal Investigator: Timothy Cannon, MD
      • Contact: Stephanie Van Bebber, MSc; Phone Number: 571-472-0213; Email: Stephanie.VanBebber@inova.org
      • Contact: Keary Janet, BS; Phone Number: 571-472-0224; Email: keary.janet@inova.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Investigators: Principal Investigator: Timothy Cannon, MD, Inova Schar Cancer Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Anticipated): August 31, 2025
• Study Completion (Anticipated): August 31, 2025

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: U21-10-4567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No