Mapping the peritoneal immune system to identify novel immunomodulatory treatment options for diseases with peritoneal involvement.

Recruiting

• Conditions: 10027476; 10017990; 10027665; Gastric- and colon cancer (cancer of the stomach and large intestine); peritoneal metastasis (spreading of the cancer to the abdominal wall)

• Registration Number: NL-OMON52795
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

Both males and females will be included in this study. To minimize the
potential risk of age and gender differences in the peritoneal immune system,
we will age and gender-match the samples for analyses from the control groups
and the peritoneal metastases group.
Patients are eligible when aged >18 old.

Exclusion Criteria

The following general criteria will lead to exclusion from participation in
this study:
a. No informed consent is provided by patient or its legal representative
b. Signs of bleeding in the peritoneal cavity, as this will lead to
contamination of blood immune cells in the peritoneal cavity
c. Presence of intra-abdominal medical devices or corpus aliena, as this could
elicit a local inflammatory response
d. History of active peritoneal dialysis (CAPD)
e. Recent history (<1 year) of, or active episode of peritonitis
f. History of cisplatin or oxalitplatin use. These patients will be excluded as
it can hamper the analyses of samples for CyTOF.

Specific exclusion criteria per group:
Group 1: controls in which peritoneal involvement of disease is not to be
suspected
a. Patients will be excluded is there are signs of inflammation such as
increased CRP or leukocytosis.
b. Per-operative signs of inflammation in the peritoneal cavity such as
adhesions, cholecystitis (in the cholecystectomy group).

Group 2-6: patients with cancer with/without peritoneal metastases
a. Perforation of the gastrointestinal tract

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The goal of this explorative study is to establish a correlation map between<br /><br>the healthy peritoneal immune compartment and the peritoneal immune composition<br /><br>in patients with peritoneal metastasized disease.<br /><br>Clustering of transcriptional (scRNA-Seq) and cell surface protein expression<br /><br>(CyTOF) allows for identification of immune cell populations and our main study<br /><br>parameter will be differences in immune cell populations between peritoneal<br /><br>fluid from patients without peritoneal involvement and peritoneal fluid of<br /><br>patients with peritoneal involvement. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>