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

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Mesothelioma

Treatments: Other: CLDN15/VIM Test; Other: MPT Test

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03683680

18-220

CA120528 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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240 participants in 1 patient group

MRiS

Experimental group

Description:

* The specimens to be collected will include at least five pleural biopsy samples * MPT test and the CLDN15/VIM test will be performed

Treatment:

Other: CLDN15/VIM Test

Other: MPT Test