Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer

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

Interventions

BEHAVIORAL

Semi Quantitative Food Frequency Questionnaire (SQFFQ)

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

Sponsors & Collaborators

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

  collaborator UNKNOWN

• Ospedale Civile Guglielmo da Saliceto, Piacenza, Italy

  collaborator UNKNOWN

• Centro di Riferimento Oncologico di Aviano, Aviano, Italy

  collaborator UNKNOWN

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

  collaborator OTHER

• Gastroenterology Unit, University Hospital of Padova, Padova, Italy

  collaborator UNKNOWN

• Azienda Ospedaliero-Universitaria Careggi

  collaborator OTHER

• IRCCS Arcispedale S. Maria Nuova - Azienda Ospedaliera di Reggio Emilia, Reggio Emilia, Italy

  collaborator UNKNOWN

• Azienda Ospedaliera San Gerardo di Monza, Monza, Italy

  collaborator UNKNOWN

• Azienda ULSS5 Polesana, Rovigo, Italy

  collaborator UNKNOWN

• Istituto Tumori Regina Elena - IRCCS IFO, Roma, Italy

  collaborator UNKNOWN

• University Hospital of Padova, Padova, Italy

  collaborator UNKNOWN

• IRCCS De Bellis, Castellana Grotte, Italy

  collaborator UNKNOWN

• University Hospital HELIOS Klinikum Wuppertal, Center for Hereditary Tumors, University of Witten-Herdecke, Wuppertal, Germany

  collaborator UNKNOWN

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• Hospital Clinic of Barcelona

  collaborator OTHER

• Helsinki University Hospital, Helsinki, Finland

  collaborator UNKNOWN

• Oslo University Hospital (OUS), Institute for Cancer Genetics and Informatics Norwegian Radium Hospital, Oslo, Norway

  collaborator UNKNOWN

• Department of Medicine University of Chicago Medicine, Illinois, USA

  collaborator UNKNOWN

• University of Colorado Hospital, CO, USA

  collaborator UNKNOWN

• University of Michigan Ann Arbor, Michigan, USA

  collaborator UNKNOWN

• Columbia University Irving Medical Center, New York, NY

  collaborator UNKNOWN

• The James Comprehensive Cancer Center, Columbus, OH, USA

  collaborator UNKNOWN

• Ohio State University

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Victoria, Australia

  collaborator UNKNOWN

• San Raffaele University

  lead OTHER

Principal Investigators

• Giulia Martina Cavestro, MD PhD · IRCCS San Raffaele Scientific Institute

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-12-05

Primary Completion

2030-01-31

Completion

2035-01-31

Countries

• United States
• Finland
• Germany
• Italy
• Norway
• Spain

Study Locations