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RECRUITINGOBSERVATIONAL

Exogenous and Endogenous 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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 ± 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. Variables of interest: age, sex, ethnicity, BMI at the time of eoCRC diagnosis and at 18 years old, country, tobacco smoking at the time of eoCRC diagnosis and at 18 years old, sitting time, TV-viewing time, moderate-to-vigorous physical activity (MVPA), waist circumference (cm), home blood pressure levels (mmHg), fasting blood glucose (mg/dl), regular consumption of aspirin/NSAID, calcium and folate supplements, oral contraceptive agents, post-menopausal hormones and years of consumptions, if the filled questionnaire reflects diet for the last 5-10 years before. Cases only: date of eoCRC diagnosis, symptoms at diagnosis, eoCRC localization, eoCRC stage, histological diagnosis, type of surgery, and date (if performed), chemotherapy and radiotherapy (if performed), vital status and duration of follow-up, family history of CRC and other cancers (uterus, ovary, stomach, small intestine, urinary tract/bladder/kidney, bile ducts, brain, pancreas, skin tumors), type of germline pathogenetic variant (if performed). Before the case-control study, three non-consecutive 24-hour Dietary Recalls (24hDRs) will validate the SQFFQ. The SQFFQ will be administered to the validation study group during three non-consecutive calls, including one non-weekday (30-minute 24-h-recall computer-aided personal interview). Primary Objective To measure the relative risk of specific dietary and lifestyle factors (smoking habit, alcohol intake, physical activity) for early-onset colorectal cancer in countries where eoCRC incidence is increasing versus stable/decreasing

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

Semi Quantitative Food Frequency Questionnaire (SQFFQ)

The SQFFQ quantifies the frequency of consumption of each food and drink and the following list of variables: * date of birth * sex * ethnicity * weight (kg) * height (m) * BMI (kg/m2) at the time of eoCRC diagnosis and at 18 years old * country where they live permanently * tobacco smoking at the time of eoCRC diagnosis and at 18 years old * sitting time * TV-viewing time * moderate-to-vigorous physical activity (MVPA) * waist circumference (cm) * home blood pressure levels (mmHg) * fasting blood glucose (mg/dl) * regular consumption of aspirin/NSAID and years of consumptions * calcium and folate supplements and years of consumptions * oral contraceptive agents and years of consumptions * post-menopausal hormones and years of consumptions

Locations (8)

Department of Medicine-Gastroenterology, Denver Veterans Affairs Medical Center, University of Colorado Hospital
Denver, Colorado, United States
Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine University of Chicago Medicine
Chicago, Illinois, 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, Lombardy, Italy
Division of Cancer Medicine, Oslo University Hospital (OUS), Institute for Cancer Genetics and Informatics Norwegian Radium Hospital
Oslo, Norway
Department of Gastroenterology, Hospital Clínic de Barcelona, University of Barcelona
Barcelona, Spain