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Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer

Recruitingn/aAges 18 Years - 49 YearsAllSan Raffaele University
NCT05732623 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

An increase in early-onset colorectal cancers (eoCRC), defined as a CRC before 50 years, is confirmed globally. CRC pathogenesis has been associated with several risk factors (family history, germline pathogenic variants, obesity, alcohol, physical activity, red meat, and a Western diet). Design: an international, multicenter, retrospective case-control study of prospectively enrolled patients; low-risk intervention study as it will perform a fecal occult blood test Endpoint: predictive power of a semi-quantitative food frequency questionnaire (SQFFQ) developed for eoCRC. Cases: Patients with a recent diagnosis of eoCRC (within 2 years from enrollment). Controls: matched by age (matching range ยฑ 5 years) and sex. Healthy volunteers will be mainly enrolled among workers within the participating hospital center. The enrolled healthy volunteers will perform a fecal occult blood test. V

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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
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What it tests

  • Semi Quantitative Food Frequency Questionnaire (SQFFQ)
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Where

8 sites
Department of Medicine-Gastroenterology, Denver Veterans Affairs Medical Center, University of Colorado Hospital
Denver, United States
Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine University of Chicago Medicine
Chicago, United States
Department of Gastrointestinal Surgery, Helsinki University Hospital
Helsinki, Finland
Department of General, Visceral and Transplant Surgery, Hospital of the University of Munich (LMU)
Munich, Germany
Gabriela Moslein
Wuppertal, Germany
Prof Giulia Martina Cavestro, MD PhD
Milan, Italy
Division of Cancer Medicine, Oslo University Hospital (OUS), Institute for Cancer Genetics and Informatics Norwegian Radium Hospital
Oslo, Norway
Department of Gastroenterology, Hospital Cliฬnic de Barcelona, University of Barcelona
Barcelona, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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