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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
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 30, 2022
    Last Updated
    September 9, 2022
    Sponsor
    Universitair Ziekenhuis Brussel
    Collaborators
    Vrije Universiteit Brussel
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    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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