Dissecting the Biology of Early-onset Colorectal Cancer

Study of the Biology of Colorectal Cancer in Early-onset Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05916443

Enrollment

Registered

2023-06-23

Start date

2023-08-01

Completion date

2025-09-30

Last updated

2023-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Non-availability of informed consent.

Design outcomes

Primary

Measure	Time frame	Description
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).
Identification of obesity-associated adipokines in EO-CRC obese patients	2 years	Elisa/Luminex assay evaluation of obesity-associated adipokines concentration
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.

Outcome results