NCT05732623 · San Raffaele University
Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer
(DEMETRA)
What this study is about
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).
View original scientific description
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).
Interventions
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
Primary outcome measures
Diet and the risk of eoCRC
Time frame: 10 years
To quantify the relative risk of early-onset colorectal cancer for specific dietary and lifestyle risk factors (including the risk for eoCRC for * tobacco smoking at the time of eoCRC diagnosis and at 18 years old * alcohol consumption * physical activity * sex * ethnicity * BMI at the time of eoCRC diagnosis and at 18 years old * country of origin * Daily sitting time * Daily TV-viewing time * Daily moderate-to-vigorous physical activity (MVPA) * waist circumference (cm) * home blood pressure levels (mmHg) * Fasting blood glucose (mg/dl) * Regular consumption of aspirin/NSAID * Regular consumption of calcium and folate supplements * Regular use of oral contraceptive agents and years of consumptions * Regular use of post-menopausal hormones and years of consumptions Results will be stratified by countries where the incidence of eoCRC is increasing versus stable/decreasing
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Denver, Colorado
- Chicago, Illinois
Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Ospedale Civile Guglielmo da Saliceto, Piacenza, Italy, Centro di Riferimento Oncologico - Aviano, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, University Hospital Padova, Azienda Ospedaliero-Universitaria Careggi, IRCCS Arcispedale S. Maria Nuova - Azienda Ospedaliera di Reggio Emilia, Reggio Emilia, Italy, Azienda Ospedaliera San Gerardo di Monza, Azienda ULSS5 Polesana, Rovigo, Italy, Istituto Tumori Regina Elena - IRCCS IFO, Roma, Italy, IRCCS De Bellis, Castellana Grotte, Italy, University Hospital HELIOS Klinikum Wuppertal, Center for Hereditary Tumors, University of Witten-Herdecke, Wuppertal, Germany, Ludwig-Maximilians - University of Munich, Hospital Clinic of Barcelona, Helsinki University Hospital, Helsinki, Finland, Oslo University Hospital (OUS), Institute for Cancer Genetics and Informatics Norwegian Radium Hospital, Oslo, Norway, University of Chicago, University of Colorado Hospital, CO, USA, University of Michigan Ann Arbor, Michigan, USA, Columbia University, The James Comprehensive Cancer Center, Columbus, OH, USA, Ohio State University, The Cleveland Clinic, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Victoria, Australia
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Data: ClinicalTrials.gov · synced Apr 24, 2026 · Source of record for eligibility and locations