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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: Recruiting study of Colorectal Cancer and Diet Habit, sponsored by San Raffaele University.

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 1,539-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (49% higher). The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

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

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

FieldValue
Enrollment Target 2,300 participants
Start Date 2022-12-05
Est. Completion 2035-01
San Raffaele University

2 total trials

What NCT05732623 shows while recruiting

NCT05732623 is an observational study that tracks outcomes without assigning an intervention. Its 2,300 participants enrollment target places it among the larger protocols in the corpus, above the 1,539-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (49% higher).

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 lists 8 locations in 4 states (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.

Similar trials for Colorectal Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05732623's enrollment target sits among peer trials

2,300 29th of 381 higher than 353 of 381 other Colorectal Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05732623, the US trial registry maintained by the National Library of Medicine. NCT05732623 (large enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.