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

Mesothelioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03683680
• Other study ID #: 18-220
• Secondary ID: CA120528
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2018
• Est. completion date: October 1, 2025

Study information

• Verified date: January 2023
• Source: Dana-Farber Cancer Institute
• Contact: Raphael Bueno, MD
• Phone: 617-732-5690
• Email: rbueno[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Mesothelioma
• Mesothelioma, Malignant

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-treatment Prognostic Algorithm Validation	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	4 years
Secondary	Evaluation of Molecular Tests Base on RNA Expression	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.	4 years