Dissecting the Biology of Early-onset Colorectal Cancer

NCT05916443 | Unknown

• 1 other identifier: 5527
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (3)

• Isolation and characterization of EO-CRC-derived CSCs

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

  2 years

• Identification of obesity-associated adipokines in EO-CRC obese patients

  Elisa/Luminex assay evaluation of obesity-associated adipokines concentration

  2 years

• Identification of EO-CRC specific signatures and pathways

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

  2 years

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

National multicenter study, enrolling approximately 30 patients with colorectal cancer, males and females, no pediatric age.

You may qualify if:

• age \> 18 and \< 50 years ;
• Written informed consent

You may not qualify if:

• Non-availability of informed consent.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

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

Study Design

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

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 23, 2023
• Study Start: August 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2025
• Last Updated: July 24, 2023

Record last verified: 2023-04