Observational study on early-onset colorectal cancer
Early-Onset Colorectal Cancer: An Observational Retrospective and Prospective Multicenter Study - (The HEBE Study)
This study looks at young adults with colorectal cancer to learn more about the disease and find new treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Niguarda Hospital Academic / other |
| Locations | 1 site (Milan, Milano) |
| Trial ID | NCT06965335 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-40 diagnosed with colorectal cancer or those over 60 diagnosed with standard-onset colorectal cancer.
Not a fit: Patients diagnosed with colorectal cancer outside the specified age ranges may not benefit from this study.
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 performed: Other studies have shown success in exploring the biology of colorectal cancer, but this specific focus on early-onset cases is relatively novel.
Eligibility criteria
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 this trial is running
Milan, Milano
- ASST Grande Ospedale Metropolitano Niguarda — Milan, Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Salvatore Siena, MD
- Email: salvatore.siena@ospedaleniguarda.it
- Phone: +39 02 6444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.