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 volunteersQualifiers
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
Single group
Treatments tested in this trial
MPT Test
Other interventionmolecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms
CLDN15/VIM Test
Other interventionmolecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
Sponsors and contacts
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Dana-Farber Cancer Institute
Lead sponsor
National Cancer Institute (NCI)
Collaborator