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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.

Tracking Information
First Received DateSeptember 21, 2018
Last Changed DateFebruary 9, 2019
Start DateOctober 31, 2018
Anticipated Primary Completion DateJanuary 1, 2022
Primary Outcome Measures

Pre-treatment Prognostic Algorithm Validation [Time Frame: 4 years]

Secondary Outcome Measures

Evaluation of Molecular Tests Base on RNA Expression [Time Frame: 4 years]

Descriptive Information
Study TypeInterventional
  • Mesothelioma
  • Other: MPT Test
  • Other: CLDN15/VIM Test
Study Arms / Comparison Groups1 / 0
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

Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment240
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Raphael Bueno, MD
Phone: 617-732-5690
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,

Administrative Information
Responsible PartyPrincipal Investigator
SponsorDana-Farber Cancer Institute
Verification DateFebruary 2019
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