Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer

NCT05732623 | Recruiting DMC

• 1 other identifier: DEMETRA2020.0001
• Study Type: observational
• Target: 2,300
• Locations: 6 countries
• Sites: 8

Brief Summary

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

Conditions

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

Keywords

Early onset; Young onset; Young adult; Colon cancer; Rectal cancer; Cancer genetics; Cancer risk factors; Diet

Outcome Measures

Primary Outcomes (1)

• Diet and the risk of eoCRC

  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

  10 years

Study Arms (2)

Early onset colorectal cancer

Patients with colorectal cancer diagnosed before the age of 50 years

Behavioral: Semi Quantitative Food Frequency Questionnaire (SQFFQ)

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)

Behavioral: Semi Quantitative Food Frequency Questionnaire (SQFFQ)

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

Control; Early onset colorectal cancer

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

at least 300 patients in total (100 at IRCCS San Raffaele Scientific Institute) with a recent diagnosis of eoCRC (diagnosis made within 2 years prior to enrollment), aged 18-49 years, will be prospectively recruited at least 600 Healthy controls (HCs) totally (200 at IRCCS San Raffaele Scientific Institute), matched by age (matching range ± 5 years) and sex with eoCRCs will be prospectively enrolled. Healthy volunteers will be mainly enrolled among workers within the participating hospital center, followed regularly by preventive medicine. This enrollment will be carried out by e-mail invitation disseminated through the hospital's official mailing list

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• San Raffaele University: lead
• Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy: collaborator
• Ospedale Civile Guglielmo da Saliceto, Piacenza, Italy: collaborator
• Centro di Riferimento Oncologico di Aviano, Aviano, Italy: collaborator
• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: collaborator
• Gastroenterology Unit, University Hospital of Padova, Padova, Italy: collaborator
• Azienda Ospedaliero-Universitaria Careggi: collaborator
• IRCCS Arcispedale S. Maria Nuova - Azienda Ospedaliera di Reggio Emilia, Reggio Emilia, Italy: collaborator
• Azienda Ospedaliera San Gerardo di Monza, Monza, Italy: collaborator
• Azienda ULSS5 Polesana, Rovigo, Italy: collaborator
• Istituto Tumori Regina Elena - IRCCS IFO, Roma, Italy: collaborator
• University Hospital of Padova, Padova, Italy: collaborator
• IRCCS De Bellis, Castellana Grotte, Italy: collaborator
• University Hospital HELIOS Klinikum Wuppertal, Center for Hereditary Tumors, University of Witten-Herdecke, Wuppertal, Germany: collaborator
• Helsinki University Hospital, Helsinki, Finland: collaborator
• Oslo University Hospital (OUS), Institute for Cancer Genetics and Informatics Norwegian Radium Hospital, Oslo, Norway: collaborator
• Department of Medicine University of Chicago Medicine, Illinois, USA: collaborator
• University of Colorado Hospital, CO, USA: collaborator
• University of Michigan Ann Arbor, Michigan, USA: collaborator
• Columbia University Irving Medical Center, New York, NY: collaborator
• The James Comprehensive Cancer Center, Columbus, OH, USA: collaborator
• Ohio State University: collaborator
• The Cleveland Clinic: collaborator
• Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Victoria, Australia: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• Hospital Clinic of Barcelona: collaborator

Study Sites (8)

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

Denver, Colorado, 80045, United States

RECRUITING

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

Chicago, Illinois, 60637, United States

RECRUITING

Department of Gastrointestinal Surgery, Helsinki University Hospital

Helsinki, Finland

RECRUITING

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

Munich, Germany

RECRUITING

Gabriela Moslein

Wuppertal, Germany

RECRUITING

Prof Giulia Martina Cavestro, MD PhD

Milan, Lombardy, 20132, Italy

RECRUITING

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

Oslo, Norway

RECRUITING

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

Barcelona, Spain

RECRUITING

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Related Links

• Early onset colorectal cancer, first international scientific meeting
• Video interview on the early onset colorectal cancer

MeSH Terms

Conditions

Colorectal Neoplasms; Feeding Behavior; Risk Reduction Behavior; Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior, Animal; Behavior

Study Officials

• Giulia Martina Cavestro, MD PhD

  IRCCS San Raffaele Scientific Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulia Martina Cavestro, MD PhD

CONTACT

0226435508; cavestro.giuliamartina@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Cavestro Giulia Martina

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 17, 2023
• Study Start: December 5, 2022
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2035
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 5-10 days after receiving and approving a request
• Access Criteria: Individual participant data may be made available upon reasonable request

Locations

DE (2); FI (1); US (2); ES (1); IT (1); NO (1)