Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-49
SponsorSan Raffaele University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

2,300 Participants
are divided into 2 treatment groups
Group A: Early onset colorectal cancer1 intervention
Group B: Control1 intervention

Trial outcomes

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

Time frame
10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

San Raffaele University

Lead sponsor

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

Collaborator

Ospedale Civile Guglielmo da Saliceto, Piacenza, Italy

Collaborator

Centro di Riferimento Oncologico - Aviano

Collaborator

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Collaborator

University Hospital Padova

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

Collaborator

Azienda ULSS5 Polesana, Rovigo, Italy

Collaborator

Istituto Tumori Regina Elena - IRCCS IFO, Roma, 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

Ludwig-Maximilians - University of Munich

Collaborator

Hospital Clinic of Barcelona

Collaborator

Helsinki University Hospital, Helsinki, Finland

Collaborator

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

Collaborator

University of Chicago

Collaborator

University of Colorado Hospital, CO, USA

Collaborator

University of Michigan Ann Arbor, Michigan, USA

Collaborator

Columbia University

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