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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Behavioral
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: t
View:

• 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.

Locations
United States
Colorado
Department of Medicine-Gastroenterology, Denver Veterans Affairs Medical Center, University of Colorado Hospital
RECRUITING
Denver
Illinois
Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine University of Chicago Medicine
RECRUITING
Chicago
Other Locations
Finland
Department of Gastrointestinal Surgery, Helsinki University Hospital
RECRUITING
Helsinki
Germany
Department of General, Visceral and Transplant Surgery, Hospital of the University of Munich (LMU)
RECRUITING
Munich
Gabriela Moslein
RECRUITING
Wuppertal
Italy
Prof Giulia Martina Cavestro, MD PhD
RECRUITING
Milan
Norway
Division of Cancer Medicine, Oslo University Hospital (OUS), Institute for Cancer Genetics and Informatics Norwegian Radium Hospital
RECRUITING
Oslo
Spain
Department of Gastroenterology, Hospital Clínic de Barcelona, University of Barcelona
RECRUITING
Barcelona
Contact Information
Primary
Giulia Martina Cavestro, MD PhD
cavestro.giuliamartina@hsr.it
0226435508
Time Frame
Start Date: 2022-12-05
Estimated Completion Date: 2035-01
Participants
Target number of participants: 2300
Treatments
Early onset colorectal cancer
Patients with colorectal cancer diagnosed before the age of 50 years
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)
Sponsors
Collaborators: Ospedale Civile Guglielmo da Saliceto, Piacenza, Italy, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, Victoria, Australia, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy, Oslo University Hospital (OUS), Institute for Cancer Genetics and Informatics Norwegian Radium Hospital, Oslo, Norway, University Hospital of Padova, Padova, Italy, Columbia University Irving Medical Center, New York, NY, The Cleveland Clinic, The James Comprehensive Cancer Center, Columbus, OH, USA, Department of Medicine University of Chicago Medicine, Illinois, USA, Gastroenterology Unit, University Hospital of Padova, Padova, Italy, Azienda Ospedaliero-Universitaria Careggi, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Istituto Tumori Regina Elena - IRCCS IFO, Roma, Italy, IRCCS De Bellis, Castellana Grotte, Italy, Centro di Riferimento Oncologico di Aviano, Aviano, Italy, Hospital of the University of Munich (LMU), Campus Großhadern, Munich, Germany, University of Colorado Hospital, CO, USA, IRCCS Arcispedale S. Maria Nuova - Azienda Ospedaliera di Reggio Emilia, Reggio Emilia, Italy, Azienda ULSS5 Polesana, Rovigo, Italy, University Hospital HELIOS Klinikum Wuppertal, Center for Hereditary Tumors, University of Witten-Herdecke, Wuppertal, Germany, University of Michigan Ann Arbor, Michigan, USA, Ohio State University, Helsinki University Hospital, Helsinki, Finland, Azienda Ospedaliera San Gerardo di Monza, Monza, Italy
Leads: San Raffaele University

This content was sourced from clinicaltrials.gov