Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MPT Test, CLDN15/VIM Test.
- Who it may be relevant to
- Registry conditions: Mesothelioma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Other MPT Test
molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms - Other CLDN15/VIM Test
molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms
Primary outcome measures
- Pre-treatment Prognostic Algorithm Validation [Time frame: 4 years]
Secondary outcome measures (1)
- Evaluation of Molecular Tests Base on RNA Expression [Time frame: 4 years]
Eligibility criteria
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,
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Brigham and Women's Hospital — Boston
Identifiers
NCT: NCT03683680 · 18-220 · CA120528