SingleCell: Single-Cell Transcriptomics of the Peritoneal Microenvironment of Colorectal PC

Sponsor

University Hospital, Ghent (Other)

Overall Status

Recruiting

CT.gov ID

NCT05676372

Collaborator

Flemish institute of biotechnology (VIB) (Other)

Enrollment

Location

54.5

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Single cell transcriptomics of CRC PC samples

Condition or Disease	Intervention/Treatment	Phase
Peritoneal Metastases	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 Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 16, 2020

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 30, 2024

Outcome Measures

Primary Outcome Measures

Single-cell transcriptomics [24 months]
A transcriptional single-cell RNA seq atlas of gene expression data will be reported

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing CRS+HIPEC for PC of colorectal origin

Exclusion Criteria:

Previous HIPEC/PIPAC

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Ghent	Ghent	Oost-Vlaanderen	Belgium	9000

Sponsors and Collaborators

University Hospital, Ghent
Flemish institute of biotechnology (VIB)

Investigators

Principal Investigator: Wim Ceelen, MD, PhD, UZ Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT05676372

Other Study ID Numbers:

BC-6978

First Posted:

Jan 9, 2023

Last Update Posted:

Jan 9, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasm Metastasis

Study Results

No Results Posted as of Jan 9, 2023