Dissecting the Biology of Early-onset Colorectal Cancer

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Not yet recruiting
CT.gov ID

Study Details

Study Description

Brief Summary

Contrarily to late-onset (LO) colorectal cancer (CRC), early-onset (EO) CRC incidence is increasingly growing. Several factors, such as obesity, chronic inflammation, and intestinal dysbiosis, can increase the general risk of CRC. However, little is known about the biology of EO-CRC. To evaluate whether such selective rise in the incidence of EO-CRC patients mirrors a distinct transcriptomic profile, the investigators will first dissect EO-CRC's transcriptomic landscape.

Then, the investigators will investigate the colorectal cancer stem cell (CSC) compartment by in vitro functional assays and RNA-seq analysis. Because our preliminary data indicate an increased aggressiveness of the tumor microenvironment (TME) in EO-CRC,the investigators propose to investigate the CSC niche and the interaction with the TME to dissect the molecular and cellular pathways occurring in EO-CRC.

A cohort of 30 EO-CRC patients (<50 years old) will be enrolled and fully characterized. About 10 EO-CRC-derived CSCs in the form of organoids and spheroids will be generated. Since the relevant differences between CR-CSCs isolated from EO-CRC vs LO-CRC patients are still unknown, the investigators will gain information about their specific features such as clonogenic activity, tumorigenic/invasive capacity, and about differences in the mechanisms regulating their cross-talk with TME components.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Time Perspective:
    Official Title:
    Study of the Biology of Colorectal Cancer in Early-onset Patients
    Anticipated Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Jun 30, 2024
    Anticipated Study Completion Date :
    Sep 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Isolation and characterization of EO-CRC-derived CSCs [2 years]

      Identification of EO-CRC-derived CSCs by cytofluorimetry and immunofluorescence analyses (Percentage of cells positive for CD133, CD24, CD44 and CD44v6 expression).

    2. Identification of obesity-associated adipokines in EO-CRC obese patients [2 years]

      Elisa/Luminex assay evaluation of obesity-associated adipokines concentration

    3. Identification of EO-CRC specific signatures and pathways [2 years]

      RNAseq data analysis of differentially expressed genes in EO-CRC-derived CSCs compared with LO-CRC-derived CSCs.

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • age > 18 and < 50 years ;

    • Written informed consent

    Exclusion Criteria:
    • Non-availability of informed consent.

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • 5527
    First Posted:
    Jun 23, 2023
    Last Update Posted:
    Jun 23, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 23, 2023