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Trial Title:
Dissecting the Biology of Early-onset Colorectal Cancer
NCT ID:
NCT05916443
Condition:
Colon Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
National multicenter study, enrolling approximately 30 patients with colorectal cancer,
males and females, no pediatric age.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- age > 18 and < 50 years ;
- Written informed consent
Exclusion Criteria:
- Non-availability of informed consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
50 Years
Healthy volunteers:
No
Start date:
August 1, 2023
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05916443
