Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer

Part of paid clinical trials in Denver, Colorado.

Sponsor
San Raffaele University
Study ID
NCT05732623
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • Semi Quantitative Food Frequency Questionnaire (SQFFQ) — BEHAVIORAL
    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

Study Details

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

Key Dates

Start date
Dec 5, 2022
Status verified
Apr 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2035

Study Design

Enrollment
2,300 participants (estimated)

Arms

  • Arm: Early onset colorectal cancer
    Patients with colorectal cancer diagnosed before the age of 50 years
  • Arm: Control
    Individuals meeting all the following: * aged \<50 years * no history of colorectal cancer * at least one negative screening test (at least a fecal occult blood test with high sensitivity)

Primary Outcome Measure

Diet and the risk of eoCRC [ Time Frame: 10 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Department of Medicine-Gastroenterology, Denver Veterans Affairs Medical Center, University of Colorado HospitalDenverColorado80045
Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine University of Chicago MedicineChicagoIllinois60637
Sonia Kupfer
[email protected]

Find similar trials in Denver, CO

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Department of Medicine-Gastroenterology, Denver Veterans Affairs Medical Center, University of Colorado Hospital· Denver, COSection of Gastroenterology, Hepatology, and Nutrition, Department of Medicine University of Chicago Medicine· Chicago, IL

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