Role of the Peritoneal Microenvironment in the Pathogenesis and Spread of Colorectal Carcinomatosis

Completed

• Conditions: Peritoneal Carcinomatosis
• Interventions: Procedure: Sampling peritoneal tissue

• Registration Number: NCT03777943
• Lead Sponsor: University Ghent

Brief Summary

The goal of this project is to investigate the extent and role of mesothelial - mesenchymal transition (MMT) and cancer associated fibroblasts (CAFs) in the pathogenesis of colorectal peritoneal carcinomatosis (PC).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-12
• Study First Posted: 2018-12-19
• Primary Completion: 2022-03-28
• Study Completion: 2022-03-28
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Patients presenting with colorectal peritoneal carcinomatosis

Exclusion Criteria

• Pregnancy or breast feeding
• Psychiatric pathology capable of affecting comprehension and judgment faculty
• HIPEC (hyperthermic intraperitoneal chemotherapy) or PIPAC (pressurized intraperitoneal aerosol chemotherapy) in the past
• Abdominal radiation treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cytoreductive surgery (CRS)	Sampling peritoneal tissue	In patients presenting with colorectal peritoneal carcinomatosis, peritoneal tissue will be sampled during surgery at 4 different locations.

Primary Outcome Measures

Name	Time	Method
Immunohistochemistry (IHC) analysis	Within 6 months after collection of the samples	Extensive IHC analysis will be performed including CD44, integrins, ICAM-1, hyaluronate, and VCAM-1 (adhesion molecules); calretinin, mesothelin, WT1, cytokeratins and E-cadherin (mesothelial markers); α-SMA, FAP and podoplanin (CAF specific markers); PDGF, VEGF and EDGF (angiogenesis related markers)

Secondary Outcome Measures

Name	Time	Method
Intra-tumoral versus peritoneal vascularity	Within 6 months after collection of the samples	Vacularity will be assed using chalkley counts
Laser capture microdisssection (LCM) followed by gene expression analysis	Within 12 months after collection of the samples	Different cell types (mesothelial cells, submesothelial resident fibroblasts, CAFs) will be isolated using LCM, followed by gene expression analysis

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium