Actively Recruiting
Early-Onset Colorectal Cancer: An Observational Retrospective and Prospective Multicenter Study - The HEBE Study
Led by Niguarda Hospital · Updated on 2025-05-11
20
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating early-onset colorectal cancer (EO-CRC) in patients aged 18 to 40 compared to standard-onset colorectal cancer (SO-CRC) diagnosed at 60 years or older. This observational, retrospective and prospective multicenter study aims to better understand the biology of EO-CRC, including the role of colibactin and a detailed proteo-genomic profile, to find potential new treatment targets for this specific patient group. The study is conducted across several Italian centers and includes analysis of clinical and survival data. The study involves collecting clinicopathological data pseudonymized through a dedicated database. Tumor samples will be tested for colibactin presence using PCR techniques, and a subset of patients will undergo proteomic and genomic analyses by mass spectrometry and whole genome sequencing. These findings will be further validated with various laboratory methods. Additionally, if available, liquid biopsy plasma samples will be studied to see if tumor-related genomic or proteomic changes can be detected in blood. Participants' clinical features, survival, and treatment responses will be analyzed and compared between early- and standard-onset groups. Researchers will monitor the prevalence of colibactin and perform proteo-genomic characterization throughout the study period. The study collects real-world epidemiological data and lasts from April 2024 to June 2027. Overall, this study seeks to deepen knowledge of EO-CRC biology and its potential blood-based markers, supporting future personalized therapies.
CONDITIONS
Brief Title
Early-Onset Colorectal Cancer: An Observational Retrospective and Prospective Multicenter Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with colorectal cancer between 18 and 40 years of age (early-onset) or diagnosed at 60 years or older (standard-onset)
- Able and willing to provide informed consent if alive
- Availability of tumor tissue samples, including formalin-fixed paraffin embedded (FFPE) slides or fresh biopsy/surgical tissue as per standard care
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 32 months
Participants provide tumor tissue samples and clinical data, which are collected and analyzed to assess clinicopathological features and presence of colibactin.
1 to 2 visits depending on sample availability
Duration - Approximately 32 months
Participants' overall survival and response to standard-of-care treatments are observed using existing clinical data over time.
No additional visits; data collected from medical records
Trial Site Locations
Total: 1 location
1
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, Italy, 20162
Actively Recruiting
Research Team
S
Salvatore Siena, MD
A
Andrea Sartore Bianchi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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