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CompletedNCT03777943MMTUpdated Sep 19, 2024

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

An observational study in Peritoneal Carcinomatosis, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by University Hospital, Ghent · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
53
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Peritoneal Carcinomatosis
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 53 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients presenting with colorectal peritoneal carcinomatosis

Inclusion criteria

  • Patients presenting with colorectal peritoneal carcinomatosis

Exclusion criteria

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
53 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • ProcedureSampling 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.

06

What researchers measure

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)

    Time frame: Within 6 months after collection of the samples

Secondary outcomes

  1. Intra-tumoral versus peritoneal vascularity

    Vacularity will be assed using chalkley counts

    Time frame: Within 6 months after collection of the samples

  2. 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

    Time frame: Within 12 months after collection of the samples

07

Study locations

1 site
  • Ghent University Hospital
    Ghent, 9000, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03777943
Lead sponsor
University Hospital, Ghent
Collaborators
University Ghent, Belgian Federation Against Cancer
Responsible party
Sponsor
First posted
Dec 19, 2018
Start date
Nov 1, 2017
Primary completion
Mar 28, 2022
Completion
Mar 28, 2022
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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