Observational Study on Risk Factors for Early-Onset Colorectal Cancer

This observational study is looking into why more people under 50 are getting colorectal cancer (cancer of the colon or rectum). Researchers want to understand how diet and other factors might increase or decrease your risk. They are using a Semi Quantitative Food Frequency Questionnaire (SQFFQ) to gather information about what people eat. The study aims to see if certain diets are linked to an increased risk of early-onset colorectal cancer over 10 years. You may be able to join if you are between 18 and 49 years old. If you have been recently diagnosed with early-onset colorectal cancer, or if you have never had cancer, you might be eligible. The current recruitment status is unclear.

Study design
This is an international, multicenter, retrospective case-control study. It plans to enroll 2300 participants.
What's involved
The study involves completing a Semi Quantitative Food Frequency Questionnaire (SQFFQ). For controls, it may also involve a fecal occult blood test (FOBT) or colonoscopy.
Compensation
Not stated in the trial record.
Follow-up
The study will look at the link between diet and early-onset colorectal cancer over 10 years.

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NCT05732623

Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer

Recruiting
Not specifiedAges 18–49Observational
San Raffaele University
~2,300 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:Semi Quantitative Food Frequency Questionnaire (SQFFQ)

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diet and the risk of eoCRC
Measured over 10 years
Colorectal Cancer
Early Onset Colorectal Cancer
Diet Habit
Risk Reduction
8 sites across 7 states
Germany2
Colorado1
Illinois1
Finland1
Lombardy1
Norway1
Spain1
  • Giulia Martina Cavestro, MD PhD · PRINCIPAL_INVESTIGATOR · IRCCS San Raffaele Scientific Institute

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Eligibility criteria

Inclusion

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

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
  • Diet and the risk of eoCRC10 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