NCT05732623 Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer
| NCT ID | NCT05732623 |
| Status | Recruiting |
| Phase | — |
| Sponsor | San Raffaele University |
| Condition | Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,300 participants |
| Start Date | 2022-12-05 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,300 participants in total. It began in 2022-12-05 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Giulia Martina Cavestro, MD PhD
PRINCIPAL INVESTIGATOR
IRCCS San Raffaele Scientific Institute
Frequently Asked Questions
Who can join the NCT05732623 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 49 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05732623 currently recruiting?
Yes, NCT05732623 is actively recruiting participants. Contact the research team at cavestro.giuliamartina@hsr.it for enrollment information.
Where is the NCT05732623 trial being conducted?
This trial is being conducted at Denver, United States, Chicago, United States, Helsinki, Finland, Munich, Germany and 4 additional locations.
Who is sponsoring the NCT05732623 clinical trial?
NCT05732623 is sponsored by San Raffaele University. The principal investigator is Giulia Martina Cavestro, MD PhD at IRCCS San Raffaele Scientific Institute. The trial plans to enroll 2,300 participants.
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