Clinical trial Recruiting at 8 sites Observational Ages 18 to 49

Investigating risk factors for early-onset colorectal cancer

Official title: Diet obEsity sMoking Epigenetics geneTics biomaRkers Physical Activity: An International Multicenter Case-control Study on Endogenous and Exogenous Risk Factors in Early-onset Colorectal Cancer

Run by San Raffaele University · NCT05732623 · Data updated 2026-11-12

This study is trying to find out what lifestyle and dietary factors might increase the risk of developing colorectal cancer in people under 50.

More Colorectal Cancer trials

Quick facts

Study typeObservational
Ages18 Years to 49 Years
SexAll
Enrollment2300 (estimated)
SponsorSan Raffaele University
Academic / other
Drugs / interventionschemotherapy
Locations8 sites (Denver, Colorado and 7 other locations)
StatusRecruiting
StartedDecember 5, 2022
Main results expectedJanuary 2030
Study endsJanuary 2035
Registry record updatedApril 24, 2026
Trial IDNCT05732623 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals aged 18 to 49 who have been recently diagnosed with early-onset colorectal cancer.

Probably not a fit

Patients diagnosed with colorectal cancer at age 50 or older, or those with conditions that significantly alter dietary habits, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify both exogenous and endogenous risk factors associated with early-onset colorectal cancer (eoCRC), defined as colorectal cancer diagnosed before the age of 50. It will involve a multicenter, retrospective case-control design, where patients diagnosed with eoCRC within the last two years will be compared to healthy controls matched by age and sex. The study will utilize a semi-quantitative food frequency questionnaire to assess dietary habits and other lifestyle factors that may contribute to the development of eoCRC.

Why it matters

Potential benefit: If successful, this study could enhance understanding of dietary and lifestyle factors that contribute to early-onset colorectal cancer, potentially leading to improved prevention strategies.

How similar studies have gone: Previous studies have indicated a correlation between dietary patterns and colorectal cancer risk, suggesting that this approach may yield valuable insights.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* All sexes eligible
* (for Cases) eoCRC diagnosed between 18 and 49 years and confirmed by histology (biopsy or surgical specimen in case of surgery)
* (for Controls) negative past and present history of cancer; negative fecal occult blood test (FOBT), or negative colonoscopy.

Exclusion Criteria:

* CRC diagnosed at ≥ 50 years
* Diseases that can modify the dietary regimen (celiac disease, diabetes)
* Diseases that are known to predispose to eoCRC (personal past or recent history of inflammatory bowel disease, past history of pelvic irradiation)
* Unable to give written consents and to fill in the electronic questionnaire

Where it's running

  • Department of Medicine-Gastroenterology, Denver Veterans Affairs Medical Center, University of Colorado Hospital
    Denver, Colorado, United States
    Recruiting
  • Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine University of Chicago Medicine
    Chicago, Illinois, United States
    Recruiting
  • Department of Gastrointestinal Surgery, Helsinki University Hospital
    Helsinki, Finland
    Recruiting
  • Department of General, Visceral and Transplant Surgery, Hospital of the University of Munich (LMU)
    Munich, Germany
    Recruiting
  • Gabriela Moslein
    Wuppertal, Germany
    Recruiting
  • Prof Giulia Martina Cavestro, MD PhD
    Milan, Lombardy, Italy
    Recruiting
Show 2 more locations
  • Division of Cancer Medicine, Oslo University Hospital (OUS), Institute for Cancer Genetics and Informatics Norwegian Radium Hospital
    Oslo, Norway
    Recruiting
  • Department of Gastroenterology, Hospital Clínic de Barcelona, University of Barcelona
    Barcelona, Spain
    Recruiting

Study contacts

  • Principal investigator: Giulia Martina Cavestro, MD PhD — IRCCS San Raffaele Scientific Institute
  • Study coordinator: Giulia Martina Cavestro, MD PhD
  • Email: cavestro.giuliamartina@hsr.it
  • Phone: 0226435508

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.