Role of the Peritoneal Microenvironment in the Pathogenesis and Spread of Colorectal Carcinomatosis
MMT
1 other identifier
observational
53
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 11, 2018
CompletedFirst Posted
Study publicly available on registry
December 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2022
CompletedSeptember 19, 2024
September 1, 2024
4.4 years
December 11, 2018
September 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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); α-SMA, FAP and podoplanin (CAF specific markers); PDGF, VEGF and EDGF (angiogenesis related markers)
Within 6 months after collection of the samples
Secondary Outcomes (2)
Intra-tumoral versus peritoneal vascularity
Within 6 months after collection of the samples
Laser capture microdisssection (LCM) followed by gene expression analysis
Within 12 months after collection of the samples
Study Arms (1)
Cytoreductive surgery (CRS)
In patients presenting with colorectal peritoneal carcinomatosis, peritoneal tissue will be sampled during surgery at 4 different locations.
Interventions
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.
Eligibility Criteria
Patients presenting with colorectal peritoneal carcinomatosis
You may qualify if:
- Patients presenting with colorectal peritoneal carcinomatosis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- University Ghentcollaborator
- Belgian Federation Against Cancercollaborator
Study Sites (1)
Ghent University Hospital
Ghent, 9000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2018
First Posted
December 19, 2018
Study Start
November 1, 2017
Primary Completion
March 28, 2022
Study Completion
March 28, 2022
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share