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

Not Applicable

Recruiting

• Conditions: Mesothelioma
• Interventions: Other: MPT Test; Other: CLDN15/VIM Test

• Registration Number: NCT03683680
• Lead Sponsor: Dana-Farber Cancer Institute

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 Timeline

• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-25
• Study Start: 2018-10-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25
• Primary Completion: 2024-01-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pre-treatment Prognostic Algorithm Validation	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

Name	Time	Method
Evaluation of Molecular Tests Base on RNA Expression	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States