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Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03683680
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : January 25, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Raphael Bueno, MD, Dana-Farber Cancer Institute

Study Description
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Brief Summary:
This research study is evaluating a new method for determining stage and prognosis of individuals with malignant pleural mesothelioma.

Condition or disease Intervention/treatment Phase
Mesothelioma Other: MPT Test Other: CLDN15/VIM Test Not Applicable

Detailed Description:

The purpose of this research study is to test a new method for determining the stage and prognosis of patients with malignant pleural mesothelioma. Currently, it is not possible to accurately determine cancer stage prior to surgery or another treatment. This new method may allow doctors to better classify cancer stage and give a better estimate for prognosis prior to surgery or another treatment.

In this research study, the investigators would like to use biopsied tissue to study certain characteristics that will help test the new method for determining cancer stage and estimating prognosis.

In this research study, the investigators are...

  • Obtaining pleural specimens at the time of routine diagnostic biopsy during the participant's standard treatment.
  • Storing your biopsied tissue
  • Studying the tissue to determine if the new method of staging and prognosis is accurate and valid
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers
Actual Study Start Date : October 31, 2018
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Mesothelioma

Arms and Interventions
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Arm Intervention/treatment
Experimental: MRiS
  • The specimens to be collected will include at least five pleural biopsy samples
  • MPT test and the CLDN15/VIM test will be performed
 Other: MPT Test
molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms

Other: CLDN15/VIM Test
molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms


Outcome Measures
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Primary Outcome Measures :
  1. Pre-treatment Prognostic Algorithm Validation [ Time Frame: 4 years ]
    The primary objective is to utilize a novel prognostic algorithm to predict the outcome of MPM patients. This algorithm includes 4 different tests: molecular, radiological, and blood based. It will be performed on 240 prospectively-collected samples. A score of 0-4 will be assigned to each patient and the data will be analyzed by a statistician


Secondary Outcome Measures :
  1. Evaluation of Molecular Tests Base on RNA Expression [ Time Frame: 4 years ]
    The secondary objective is to develop new molecular signatures for distinct clusters of mesothelioma samples grouped according to their gene expression. RNA expression data will be compared between one cluster and all the other clusters and using a variety of statistical and bioinformatics tools. Two-hundred sixteen MPM cases with available RNAseq data will be divided into training and test sets to develop and test potential signatures. The signatures that define each cluster with high sensitivity and specificity will then be tested using RTPCR in a cohort of 555 prospective-collected samples.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult patients with a diagnosis of malignant pleural mesothelioma undergoing

    • diagnostic pleural biopsy
    • pleuroscopy
    • and/or VATS resections
  • Participants must be 18 years of age or older.

Exclusion Criteria:

-Any patient who is found to be unsuitable for

  • surgery,
  • treatment
  • diagnosis,
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683680


Contacts
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Contact: Raphael Bueno, MD 617-732-5690 rbueno@partners.org

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Raphael Bueno, MD    617-732-5690    rbueno@partners.org   
Principal Investigator: Raphael Bueno, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Raphael Bueno, MD Brigham and Women's Hospital
More Information
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Responsible Party: Raphael Bueno, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03683680    
Other Study ID Numbers: 18-220
CA120528 ( Other Identifier: NCI )
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raphael Bueno, MD, Dana-Farber Cancer Institute:
Mesothelioma
Additional relevant MeSH terms:
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Mesothelioma
Mesothelioma, Malignant
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
 Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases