Single-Cell Transcriptomics of the Peritoneal Microenvironment of Colorectal PC (SingleCell)

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

Single cell transcriptomics of CRC PC samples

Study Overview

• Status: Recruiting
• Conditions: Peritoneal Metastases
• Intervention / Treatment: Procedure: CRC+HIPEC

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Wim P Ceelen, MD, PhD; Phone Number: +32 093326251; Email: wim.ceelen@ugent.be
• Study Contact Backup: Name: Jesse G Demuytere, MD; Phone Number: +32 093324278; Email: jesse.demuytere@ugent.be

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • Recruiting
      • UZ Ghent
      • Contact: Wim P Ceelen, MD,PhD; Phone Number: +32 093326251; Email: wim.ceelen@ugent.be
      • Sub-Investigator: Jesse G Demuytere, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing CRS+HIPEC

Description

Inclusion Criteria:

• Patients undergoing CRS+HIPEC for PC of colorectal origin

Exclusion Criteria:

• Previous HIPEC/PIPAC

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single-cell transcriptomics	A transcriptional single-cell RNA seq atlas of gene expression data will be reported	24 months

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Flemish institute of biotechnology (VIB)
• Investigators: Principal Investigator: Wim Ceelen, MD, PhD, UZ Ghent

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: BC-6978

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No