Early-Onset Colorectal Cancer: An Observational Retrospective and Prospective Multicenter Study

NCT06965335 | Recruiting

• 1 other identifier: 4528
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Observational, retrospective and prospective multicentric Italian study of patients diagnosed with colorectal cancer between age 18-40, aiming at underpinning the biology of vEO-CRC, including colibactin as well as a broader proteo-genomic characterization, to identify potential new therapeutic targets specifically directed to this peculiar subset of patients.

Conditions

Colo-rectal Cancer

Keywords

Early-Onset Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• clinicopathological features description

  Primaryto analyze clinicopathological features of a cohort of sporadic vEO-CRC (n=300), compared to an equal cohort of standard-onset (SO-CRC) patients diagnosed at 60 years or later;

  Apr 2024- Dec2026

• overall survival and response to standard-of-care treatments analisys

  to analyze overall survival and response to standard-of-care treatments of a cohort of sporadic vEO-CRC (n=300), compared to an equal cohort of standard-onset (SO-CRC) patients diagnosed at 60 years or later;

  Apr 2024- Dec2026

Secondary Outcomes (2)

• prevalence of colibactin assessment

  Apr 2024- Dec2026

• perform a proteo-genomic characterization

  Apr 2024- Dec2026

Study Arms (2)

Early-Onset(EO) Colorectal Cancer (CRC)

EO-CRC: 18-40 years of age at diagnosis

Biological: BIOLOGICAL STUDY aiming at describing clinicophatological features of EO-CRC vs SO-CRC

Standard onset (SO) Colorectal Cancer

SO-CRC diagnosed later than age 60

Biological: BIOLOGICAL STUDY aiming at describing clinicophatological features of EO-CRC vs SO-CRC

Interventions

BIOLOGICAL STUDY aiming at describing clinicophatological features of EO-CRC vs SO-CRC BIOLOGICAL

Description of clinicophatological features of EO-CRC vs SO-CRC

Early-Onset(EO) Colorectal Cancer (CRC); Standard onset (SO) Colorectal Cancer

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Colorectal cancer pts

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST Grande Ospedale Metropolitano Niguarda

Milan, Milano, 20162, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

liquid biopsy

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Salvatore Siena, MD

CONTACT

+39 02 6444; salvatore.siena@ospedaleniguarda.it

Andrea Sartore Bianchi, MD

CONTACT

+39 02 6444; andrea.sartorebianchi@ospedaleniguarda.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: April 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

IT (1)