Collection of Pleural Effusion Fluid
Primary Purpose
Solid Tumor, Pleural Effusion, Metastasis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood withdrawal
Sponsored by
About this trial
This is an interventional basic science trial for Solid Tumor
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Solid cancer patients with malignant pleural effusion
Arm Description
Solid cancer patients that have to undergo pleural evacuation because of diagnosed malignant pleural effusion mediated discomfort.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05539183
First Posted
August 30, 2022
Last Updated
September 9, 2022
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Vrije Universiteit Brussel
1. Study Identification
Unique Protocol Identification Number
NCT05539183
Brief Title
Collection of Pleural Effusion Fluid
Official Title
Collection of Pleural Effusion Fluid to Design Autologous Onco-immunological Assays
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Vrije Universiteit Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
Collect, enrich and store primary cells derived from residual pleural effusion fluid and blood at the LMCT (VUB, Belgium)
Evaluate characteristics of the cells (phenotype, function,...) and compare content of pleural effusate with blood and clinicopathologic features of the patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Pleural Effusion, Metastasis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Solid cancer patients with malignant pleural effusion
Arm Type
Experimental
Arm Description
Solid cancer patients that have to undergo pleural evacuation because of diagnosed malignant pleural effusion mediated discomfort.
Intervention Type
Procedure
Intervention Name(s)
Blood withdrawal
Intervention Description
Blood withdrawal
Primary Outcome Measure Information:
Title
Collect and compare blood, tumor and MPE-derived cell fractions
Description
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).
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Correlate cellular profiles with clinico-pathologic data
Description
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.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cleo Goyvaerts, PhD
Phone
+3224774573
Email
cleo.goyvaerts@vub.be
First Name & Middle Initial & Last Name or Official Title & Degree
Lore Decoster, MD PhD
Email
Lore.Decoster@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lore Decoster, MD PhD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Samples will be pseudonymized and processed via RedCAP
Learn more about this trial
Collection of Pleural Effusion Fluid
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