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Completed

NCT Number: NCT03777943

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

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).

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Key information

Conditions

Peritoneal Carcinomatosis Abdominal Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sampling peritoneal tissue

Procedure

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Belgian Federation Against Cancer
  • University Ghent

Registry information

Acronym: MMT

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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