Clinical trial Recruiting at 1 site Observational Ages 18 to 40

Observational study on early-onset colorectal cancer

Official title: Early-Onset Colorectal Cancer: An Observational Retrospective and Prospective Multicenter Study - (The HEBE Study)

Run by Niguarda Hospital · NCT06965335 · Data updated 2026-11-12

This study looks at young adults with colorectal cancer to learn more about the disease and find new treatment options.

Quick facts

Study typeObservational
Ages18 Years to 40 Years
SexAll
Enrollment20 (estimated)
SponsorNiguarda Hospital
Academic / other
Locations1 site (Milan, Milano)
StatusRecruiting
StartedApril 17, 2024
Main results expectedDecember 31, 2026
Study endsJune 30, 2027
Registry record updatedMay 11, 2025
Trial IDNCT06965335 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 18-40 diagnosed with colorectal cancer or those over 60 diagnosed with standard-onset colorectal cancer.

Probably not a fit

Patients diagnosed with colorectal cancer outside the specified age ranges may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients diagnosed with colorectal cancer between the ages of 18 and 40. It aims to explore the biology of very early-onset colorectal cancer (vEO-CRC) through both retrospective and prospective data collection across multiple centers in Italy. The study will analyze clinicopathological features, survival data, and assess colibactin presence in tumor samples using advanced genomic techniques. Additionally, a subset of patients will undergo proteomic assessment to identify potential new therapeutic targets.

Why it matters

Potential benefit: If successful, this study could lead to the identification of new therapeutic targets specifically for young colorectal cancer patients.

How similar studies have gone: Other studies have shown success in exploring the biology of colorectal cancer, but this specific focus on early-onset cases is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
1. Patients with diagnosis of colorectal cancer (vEO-CRC: 18-40 years of age), or SO-CRC diagnosed later than age 60;
2. Informed consent signature from alivepatient;
3. Availability of formalin-fixed paraffin embedded (FFPE) tumor samples (5 FFPE 4uM thick slides and 10 FFPE 10 uM thick slides) and/or fresh tumor tissue retrieved from a biopsy or surgical procedure performed as per clinical standard of care.

Where it's running

  • ASST Grande Ospedale Metropolitano Niguarda
    Milan, Milano, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.