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NCT03777943 Clinical Trial

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

Peritoneal Carcinomatosis Clinical Trial

— MMT  

Official title:
Role of the Peritoneal Microenvironment in the Pathogenesis and Spread of Colorectal Carcinomatosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03777943
Other study ID # EC/2017/0784
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date March 28, 2022

Study information
Verified date December 2022
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 53
Est. completion date March 28, 2022
Est. primary completion date March 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Sampling peritoneal tissue
Resection specimen will be obtained during CRS from normal peritoneum at a distance, normal peritoneum close to a peritoneal metastasis, miliary peritoneal carcinomatosis, and established peritoneal carcinomatosis.

Locations
Country Name City State
Belgium Ghent University Hospital Ghent

Sponsors (2)
Lead Sponsor Collaborator
University Ghent Belgian Federation Against Cancer

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immunohistochemistry (IHC) analysis 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); a-SMA, FAP and podoplanin (CAF specific markers); PDGF, VEGF and EDGF (angiogenesis related markers) Within 6 months after collection of the samples
Secondary Intra-tumoral versus peritoneal vascularity Vacularity will be assed using chalkley counts Within 6 months after collection of the samples
Secondary Laser capture microdisssection (LCM) followed by gene expression analysis Different cell types (mesothelial cells, submesothelial resident fibroblasts, CAFs) will be isolated using LCM, followed by gene expression analysis Within 12 months after collection of the samples
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