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NCT05732623 · ClinicalTrials.gov registry record
Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer
A clinical trial of Colorectal Cancer and Diet Habit, sponsored by San Raffaele University.
- Recruiting
- Registry status
- 2,300
- Enrollment target
- 8
- Study locations
NCT05732623 is a study of Colorectal Cancer and Diet Habit that is actively recruiting participants, run by San Raffaele University. The registered enrollment target is 2,300 participants, above the 1,505-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (53% higher). The trial reports 8 study locations across 4 states.
The verdict
NCT05732623, a study of Colorectal Cancer and Diet Habit, is actively recruiting participants, sponsored by San Raffaele University.
- RECRUITING
- Registry status
- 2,300 participants
- Enrollment target
- 8
- Study locations
Study 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 Recall
Conditions Studied
Interventions
- BEHAVIORAL Semi Quantitative Food Frequency Questionnaire (SQFFQ)
Study Locations (8)
Other
- Department of Gastrointestinal Surgery, Helsinki University Hospital - Helsinki
- Department of General, Visceral and Transplant Surgery, Hospital of the University of Munich (LMU) - Munich
- Gabriela Moslein - Wuppertal
- Division of Cancer Medicine, Oslo University Hospital (OUS), Institute for Cancer Genetics and Informatics Norwegian Radium Hospital - Oslo
- Department of Gastroenterology, Hospital Clínic de Barcelona, University of Barcelona - Barcelona
Colorado
- Department of Medicine-Gastroenterology, Denver Veterans Affairs Medical Center, University of Colorado Hospital - Denver
Illinois
- Section of Gastroenterology, Hepatology, and Nutrition, Department of Medicine University of Chicago Medicine - Chicago
Lombardy
- Prof Giulia Martina Cavestro, MD PhD - Milan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,300 participants |
| Start Date | 2022-12-05 |
| Est. Completion | 2035-01 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05732623
The ClinicalTrials.gov registry entry for NCT05732623 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 2,300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,505-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (53% higher). The listed sponsor is San Raffaele University, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Semi Quantitative Food Frequency Questionnaire (SQFFQ) is the first listed.
NCT05732623 reports 8 study locations spanning 4 distinct geographic areas - top geographies include Other, Colorado, Illinois.
Frequently Asked Questions
What is clinical trial NCT05732623 about?
NCT05732623 is a clinical study titled "Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer". 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: ...
What is the current status of trial NCT05732623?
This trial is currently recruiting. The enrollment target is 2,300 participants. The study started on 2022-12-05. Estimated completion is 2035-01.
What conditions does trial NCT05732623 study?
This clinical trial studies the following conditions: Colorectal Cancer, Diet Habit, Risk Reduction, Early Onset Colorectal Cancer.
What interventions are being tested in trial NCT05732623?
The interventions under investigation include: Semi Quantitative Food Frequency Questionnaire (SQFFQ) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05732623?
This trial is sponsored by San Raffaele University, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05732623 being conducted?
This trial has 8 study locations across Colorado, Illinois, Lombardy. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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