Collection of Pleural Effusion Fluid

NCT05539183 | Unknown DMC

• 1 other identifier: 22151PLEUREF
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

At the Laboratory for Molecular and Cellular Therapy (LMCT) of the Vrije Universiteit Brussel, Belgium, we study resistance mechanisms that hamper effective immunotherapy for solid cancer patients. To perform clinically relevant research, we apply autologous human material for functional assessment. The latter requires viable tumor and immune cells. Solid cancer patients with pleural metastasis often develop pleural effusion. Notably, upon pleural drainage, residual material is obtained that consists of histocompatible tumor and immune cells. Hence with this study, we want to obtain blood and pleural effusion fluid drawn from solid cancer patients with pleural metastases to:

1. 1.Collect, enrich and store primary cells derived from residual pleural effusion fluid and blood at the LMCT (VUB, Belgium)
2. 2.Evaluate characteristics of the cells (phenotype, function,...) and compare content of pleural effusate with blood and clinicopathologic features of the patients.

Conditions

Solid Tumor; Pleural Effusion; Metastasis

Outcome Measures

Primary Outcomes (1)

• Collect and compare blood, tumor and MPE-derived cell fractions

  Viable tissue will be processed to single cell suspensions at the research laboratory. Phenotype and function (= description of measurement) will be assessed using flow cytometry and in vitro immune assays (= measurement tools). Specifically we will evaluate the concentration and function of immune cells (derived from blood or pleural effusate like monocytes, macrophages, neutrophils and lymphocytes) and their interaction with autologous tumor cells (only derived from pleural effusate).

  3 years

Secondary Outcomes (1)

• Correlate cellular profiles with clinico-pathologic data

  3 years

Study Arms (1)

Solid cancer patients with malignant pleural effusion

EXPERIMENTAL

Solid cancer patients that have to undergo pleural evacuation because of diagnosed malignant pleural effusion mediated discomfort.

Procedure: Blood withdrawal

Interventions

Blood withdrawal PROCEDURE

Blood withdrawal

Solid cancer patients with malignant pleural effusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All solid cancer patients with pleural metastases undergoing pleural drainage with available tumor biopsy (upon informed consent)
• \>18 years of age

You may not qualify if:

• pregnancy
• Healthy volunteers will be included for collection of control blood samples (upon informed consent).

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Vrije Universiteit Brussel: collaborator

MeSH Terms

Conditions

Pleural Effusion; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lore Decoster, MD PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cleo Goyvaerts, PhD

CONTACT

+3224774573; cleo.goyvaerts@vub.be

Lore Decoster, MD PhD

CONTACT

Lore.Decoster@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 14, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share