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Recruiting No phase listed Observational Accepts healthy volunteers

Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer

ClinicalTrials.gov ID: NCT05732623

Public ClinicalTrials.gov record NCT05732623. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 11:07 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Diet obEsity sMoking Epigenetics geneTics biomaRkers Physical Activity: An International Multicenter Case-control Study on Endogenous and Exogenous Risk Factors in Early-onset Colorectal Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT05732623
Recruitment status
Recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
San Raffaele University
Other
Enrollment
2,300 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 49 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 4, 2022
Primary completion
Dec 31, 2029
Completion
Dec 31, 2034
Last update posted
Apr 23, 2026

2022 – 2035

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Department of Medicine-Gastroenterology, Denver Veterans Affairs Medical Center, University of Colorado Hospital Denver Colorado 80045 Recruiting
Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine University of Chicago Medicine Chicago Illinois 60637 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05732623, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 23, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05732623 live on ClinicalTrials.gov.

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