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

Sponsor
University Ghent (Other)
Overall Status
Unknown status
CT.gov ID
NCT03777943
Collaborator
Belgian Federation Against Cancer (Other)
50
Enrollment
1
Location
37
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Procedure: Sampling peritoneal tissue

Study Design

Study Type:
Observational
Anticipated 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 :
Nov 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. 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

  1. Intra-tumoral versus peritoneal vascularity [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Ghent University Hospital Ghent Belgium 9000

Sponsors and Collaborators

  • University Ghent
  • Belgian Federation Against Cancer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GIHeelkunde, Principle investigator, University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT03777943
Other Study ID Numbers:
  • EC/2017/0784
First Posted:
Dec 19, 2018
Last Update Posted:
Aug 4, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Peritoneal Neoplasms

Study Results

No Results Posted as of Aug 4, 2020