Actively Recruiting

Age: 18Years - 49Years
All Genders
Healthy Volunteers
ID05732623

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

Led by San Raffaele University · Updated on 2026-04-24

2300

Participants Needed

8

Research Sites

260 weeks

Total Duration

On this page

Sponsors

S

San Raffaele University

Lead Sponsor

F

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating early-onset colorectal cancer (eoCRC), which occurs before age 50, a condition that has been increasing worldwide. This international, multicenter case-control study explores how dietary, lifestyle, and anthropometric factors like smoking, alcohol use, physical activity, and body measurements relate to eoCRC risk. The study aims to better understand these risk factors in countries where eoCRC rates are rising compared to places with stable or decreasing rates. The study includes two parts: a validation of a semi-quantitative food frequency questionnaire (SQFFQ) using three 24-hour dietary recalls, and a retrospective case-control study with prospectively enrolled patients. Patients diagnosed with eoCRC within the last two years and healthy controls matched by age and sex will participate. Controls will undergo a fecal occult blood test to confirm health status. Data on diet, lifestyle, and clinical factors will be collected through an online platform with separate sections for participants and doctors. Participants will complete the SQFFQ reporting usual food and drink consumption over the past 2 years, along with lifestyle and anthropometric data such as BMI, smoking habits, physical activity, and medication use. Doctors will provide clinical details for patients. The study will measure the association between these factors and eoCRC risk over 10 years. Data confidentiality and ethical standards, including informed consent and GDPR compliance, are ensured. The study is expected to continue through 2035.

CONDITIONS

Brief Title

Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer

Who Can Participate

Age: 18Years - 49Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • All sexes are eligible
  • Cases: Diagnosed with early-onset colorectal cancer between 18 and 49 years, confirmed by biopsy or surgery
  • Controls: No past or present history of cancer
  • Controls: Negative fecal occult blood test or negative colonoscopy
Not Eligible

You will not qualify if you...

  • Colorectal cancer diagnosed at age 50 or older
  • Diseases that affect dietary regimen such as celiac disease or diabetes
  • Diseases predisposing to early-onset colorectal cancer, including past or recent inflammatory bowel disease or past pelvic irradiation
  • Unable to provide written consent or complete electronic questionnaire

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for controls to perform fecal occult blood test

Monitoring

Duration - Data collection refers to the 2 years prior to enrollment

Participants complete dietary and lifestyle questionnaires and provide anthropometric data through an online platform to assess risk factors related to early-onset colorectal cancer.

Online questionnaire completion with 3 non-consecutive 24-hour dietary recall calls for SQFFQ validation participants

Trial Site Locations

Total: 8 locations

1

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

Denver, Colorado, United States, 80045

Actively Recruiting

2

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

Chicago, Illinois, United States, 60637

Actively Recruiting

3

Department of Gastrointestinal Surgery, Helsinki University Hospital

Helsinki, Finland

Actively Recruiting

4

Department of General, Visceral and Transplant Surgery, Hospital of the University of Munich (LMU)

Munich, Germany

Actively Recruiting

5

Gabriela Moslein

Wuppertal, Germany

Actively Recruiting

6

Prof Giulia Martina Cavestro, MD PhD

Milan, Lombardy, Italy, 20132

Actively Recruiting

7

Division of Cancer Medicine, Oslo University Hospital (OUS), Institute for Cancer Genetics and Informatics Norwegian Radium Hospital

Oslo, Norway

Actively Recruiting

8

Department of Gastroenterology, Hospital Clínic de Barcelona, University of Barcelona

Barcelona, Spain

Actively Recruiting

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Research Team

G

Giulia Martina Cavestro, MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Increased incidence of colon cancer among individuals younger than 50 years: A 17 years analysis from the cancer registry of the municipality of Milan, Italy.

A G Russo, A Andreano, A Sartore-Bianchi...

https://pubmed.ncbi.nlm.nih.gov/31005829

Clinicopathologic and molecular features of sporadic early-onset colorectal adenocarcinoma: an adenocarcinoma with frequent signet ring cell differentiation, rectal and sigmoid involvement, and adverse morphologic features.

Daniel T Chang, Rish K Pai, Lisa A Rybicki...

https://pubmed.ncbi.nlm.nih.gov/22481281