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NCT05676372 Clinical Trial

Single-Cell Transcriptomics of the Peritoneal Microenvironment of Colorectal PC

Peritoneal Metastases Clinical Trial

— SingleCell  

Official title:
The Role of the Peritoneal Microenvironment in the Pathogenesis of Colorectal Peritoneal Carcinomatosis: Single-cell Transcriptomics

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05676372
Other study ID # BC-6978
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 16, 2020
Est. completion date December 31, 2025

Study information
Verified date December 2023
Source University Hospital, Ghent
Contact Wim P Ceelen, MD, PhD
Phone 093326251
Email wim.ceelen@ugent.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Single cell transcriptomics of CRC PC samples

Description:

Research methodology Before inclusion of patients, patients will be screened for the presence of hepatitis B, hepatitis C and HIV to ensure researcher safety. During cytoreductive surgery, a total of five samples of tumoral tissue will be acquired. Three of those samples will be utilized for ScRNASeq analysis, and two samples of a macrometastasis will be snap frozen and cryopreserved. Single-cell RNA-Sequencing analysis We will comprehensively catalog the stromal cell types in the microenvironment of colorectal cancer peritoneal metastases utilizing single-cell RNA sequencing (scRNAseq) on three samples (one of which should preferably originate from the omentum majus, to encompass milky spots) acquired from surgical waste material of patients undergoing cytoreductive surgery. After sample prelevation, samples will be transported as soon as possible while cooled and submerged in 10% PBS to the VIB facilities, where single cell suspensions will be made according to standard protocols. After cell selection by FACS (CD45+ and live/dead stain, to ensure a 50/50 mix of immune and stromal cells) and library prep, ScRNASeq will be performed. Single cell sequencing analysis will allow us to identify cell clusters that by usage of marker genes will be assigned to different known cell lineages. After annotation of data, a "landscape" of the composition of the tumor stroma will be acquired.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients undergoing CRS+HIPEC for PC of colorectal origin Exclusion Criteria: - Previous HIPEC/PIPAC

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• CRC+HIPEC
Sample prelevation of cytoreductive surgery

Locations
Country Name City State
Belgium UZ Ghent Ghent Oost-Vlaanderen

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ghent Flemish institute of biotechnology (VIB)

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Single-cell transcriptomics A transcriptional single-cell RNA seq atlas of gene expression data will be reported 24 months
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