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Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer

San Raffaele University · with Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Ospedale Civile Guglielmo da Saliceto, Piacenza, Italy · NCT05732623

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–49 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
2300
US sites recruiting
2
Study start
December 5, 2022
Record last updated
April 24, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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).

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

Being studied: Semi Quantitative Food Frequency Questionnaire (SQFFQ)

Conditions: Colorectal Cancer; Early Onset Colorectal Cancer; Diet Habit; Risk Reduction

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Department of Medicine-Gastroenterology, Denver Veterans Affairs Medical Center, University of Colorado Hospital

    Denver, CO 80045

    Site contact: Swati Patel · Swati.Patel@cuanschutz.edu

  • Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine University of Chicago Medicine

    Chicago, IL 60637

    Site contact: Sonia Kupfer · skupfer@medicine.bsd.uchicago.edu

Study contacts (from the official record)

  • Giulia Martina Cavestro, MD PhD · 0226435508 · cavestro.giuliamartina@hsr.it
Exogenous and Endogenous Risk Factors for Early-onset Colorectal… (NCT05732623) | Bored Studies