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

ConditionMesothelioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All adult patients with a diagnosis of malignant pleural mesothelioma undergoing

diagnostic pleural biopsy

pleuroscopy

and/or VATS resections

Disqualifiers

surgery,

treatment

diagnosis,

Trial design

Design model

Single group

Treatments tested in this trial

  • MPT Test

    Other intervention

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

  • CLDN15/VIM Test

    Other intervention

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

Treatment groups

240 Participants
are divided into 1 treatment group
Group A: MRiSExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
4 years

Secondary outcomes

1

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.

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator