Brief Title
Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers
Official Title
Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers
Brief Summary
This research study is evaluating a new method for determining stage and prognosis of individuals with malignant pleural mesothelioma.
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 Type
Interventional
Primary Outcome
Pre-treatment Prognostic Algorithm Validation
Secondary Outcome
Evaluation of Molecular Tests Base on RNA Expression
Condition
Mesothelioma
Intervention
MPT Test
Study Arms / Comparison Groups
MRiS
Description: The specimens to be collected will include at least five pleural biopsy samples MPT test and the CLDN15/VIM test will be performed
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
240
Start Date
October 31, 2018
Completion Date
October 1, 2023
Primary Completion Date
January 1, 2022
Eligibility 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,
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Raphael Bueno, MD, 617-732-5690, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03683680
Organization ID
18-220
Secondary IDs
CA120528
Responsible Party
Principal Investigator
Study Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Raphael Bueno, MD, Principal Investigator, Brigham and Women's Hospital
Verification Date
March 2020