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Role of the Peritoneal Microenvironment in the Pathogenesis and Spread of Colorectal Carcinomatosis (MMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03777943
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
Belgian Federation Against Cancer
Information provided by (Responsible Party):
GIHeelkunde, University Hospital, Ghent

Study Description
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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).

Condition or disease Intervention/treatment
Peritoneal Carcinomatosis Procedure: Sampling peritoneal tissue

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Role of the Peritoneal Microenvironment in the Pathogenesis and Spread of Colorectal Carcinomatosis
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Cytoreductive surgery (CRS)
In patients presenting with colorectal peritoneal carcinomatosis, peritoneal tissue will be sampled during surgery at 4 different locations.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Immunohistochemistry (IHC) analysis [ Time Frame: 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 :
  1. Intra-tumoral versus peritoneal vascularity [ Time Frame: Within 6 months after collection of the samples ]
    Vacularity will be assed using chalkley counts

  2. Laser capture microdisssection (LCM) followed by gene expression analysis [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting with colorectal peritoneal carcinomatosis
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777943


Contacts
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Contact: Wim Ceelen +32(0)93326251 wim.ceelen@ugent.be
Contact: Sarah Cosyns +32(0)93321562 sarah.cosyns@ugent.be

Locations
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Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Wim Ceelen    +32(0)93326251    wim.ceelen@ugent.be   
Sub-Investigator: Sarah Cosyns         
Sponsors and Collaborators
University Ghent
Belgian Federation Against Cancer
More Information
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Responsible Party: GIHeelkunde, Principle investigator, University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03777943    
Other Study ID Numbers: EC/2017/0784
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases