Collection of Pleural Effusion Fluid

Collection of Pleural Effusion Fluid to Design Autologous Onco-immunological Assays

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

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor; Metastasis; Pleural Effusion
• Intervention / Treatment: Procedure: Blood withdrawal

Detailed Description

Malignant pleural effusion (MPE) is characterized by the presence of malignant cells in the pleural cavity and develops in about 15% of patients with malignant disease. Two-thirds of all cases have a pleural effusion as one or sole initial manifestation of malignant disease. Primary tumors that most frequently develop MPE as metastatic disease are lung, breast cancer, and lymphoma accounting for 75% of all cases. Discomforting symptoms of MPE can include chest pain, cough, wheezing, hemoptysis, general discomfort, uneasiness, or ill feeling (malaise), shortness of breath and weight loss. To relief these discomforting symptoms, pleural drainage (evacuation) is routinely performed.

A significant number of solid cancer patients are currently being treated with immunotherapeutic drugs in first or second line or in the framework of a clinical trial. Aside from tumor cell intrinsic mechanisms, we and others previously found that non-malignant tumor infiltrated cells can also install immunotherapy resistance. Hence it remains of utmost importance to study the functional interactions between tumor cells and their non-malignant (solid) micro-environment to increase our current understanding of molecular profiles that predict responsiveness to immunotherapy. By exploiting patient-derived material, we aspire to perform more clinically relevant fundamental and translation research. The primary objective is to collect and compare blood, tumor and MPE-derived cell fractions. The secondary objective is to correlate cellular profiles with clinico-pathologic data.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cleo Goyvaerts, PhD; Phone Number: +3224774573; Email: cleo.goyvaerts@vub.be
• Study Contact Backup: Name: Lore Decoster, MD PhD; Email: Lore.Decoster@uzbrussel.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Solid cancer patients with malignant pleural effusion; Solid cancer patients that have to undergo pleural evacuation because of diagnosed malignant pleural effusion mediated discomfort.	Procedure: Blood withdrawal; Blood withdrawal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlate cellular profiles with clinico-pathologic data	We will correlate demographics and biometrical data such as pre-disease history, therapy type, progression free and overall survival and tumor histology with the % of monocytes, macrophages, neutrophils and lymphocytes per patient (obtained from the Primary Outcome Measure). For this purpose, we will use statistical analysis via R software.	3 years

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Collaborators: Vrije Universiteit Brussel
• Investigators: Principal Investigator: Lore Decoster, MD PhD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: 22151PLEUREF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Samples will be pseudonymized and processed via RedCAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No