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NCT Number: NCT03683680

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

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

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Key information

Conditions

Mesothelioma Adenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Raphael Bueno, MD

CONTACT

[email protected]

617-732-5690

Raphael Bueno, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

MPT Test

Other

molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms

CLDN15/VIM Test

Other

molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms

Primary outcomes

  1. Pre-treatment Prognostic Algorithm Validation

    Time frame: 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 outcomes

  1. Evaluation of Molecular Tests Base on RNA Expression

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Raphael Bueno, MD

CONTACT

[email protected]

617-732-5690

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2018
Primary completion
2030
Study completion
2030
First posted
Sep 25, 2018
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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