RECRUITING

Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-12-05
Study Completion:2035-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05732623

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 49 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * All sexes eligible
  2. * (for Cases) eoCRC diagnosed between 18 and 49 years and confirmed by histology (biopsy or surgical specimen in case of surgery)
  3. * (for Controls) negative past and present history of cancer; negative fecal occult blood test (FOBT), or negative colonoscopy.
  1. * CRC diagnosed at ≥ 50 years
  2. * Diseases that can modify the dietary regimen (celiac disease, diabetes)
  3. * Diseases that are known to predispose to eoCRC (personal past or recent history of inflammatory bowel disease, past history of pelvic irradiation)
  4. * Unable to give written consents and to fill in the electronic questionnaire

Contacts and Locations

Study Contact

Giulia Martina Cavestro, MD PhD
CONTACT
0226435508
cavestro.giuliamartina@hsr.it

Principal Investigator

Giulia Martina Cavestro, MD PhD
PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele Scientific Institute

Study Locations (Sites)

Department of Medicine-Gastroenterology, Denver Veterans Affairs Medical Center, University of Colorado Hospital
Denver, Colorado, 80045
United States
Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine University of Chicago Medicine
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: San Raffaele University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-05
Study Completion Date2035-01

Study Record Updates

Study Start Date2022-12-05
Study Completion Date2035-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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