Investigating risk factors for early-onset colorectal cancer
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
This study is trying to find out what lifestyle and dietary factors might increase the risk of developing colorectal cancer in people under 50.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2300 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | All |
| Sponsor | San Raffaele University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Denver, Colorado and 7 other locations) |
| Trial ID | NCT05732623 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 to 49 who have been recently diagnosed with early-onset colorectal cancer.
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.
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 performed: Previous studies have indicated a correlation between dietary patterns and colorectal cancer risk, suggesting that this approach may yield valuable insights.
Eligibility criteria
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 this trial is running
Denver, Colorado and 7 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.