Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers
2 other identifiers
interventional
240
1 country
1
Brief Summary
This research study is evaluating a new method for determining stage and prognosis of individuals with malignant pleural mesothelioma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2018
CompletedFirst Posted
Study publicly available on registry
September 25, 2018
CompletedStudy Start
First participant enrolled
October 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2030
May 5, 2026
April 1, 2026
11.2 years
September 21, 2018
April 29, 2026
Conditions
Keywords
Outcome Measures
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
4 years
Secondary Outcomes (1)
Evaluation of Molecular Tests Base on RNA Expression
4 years
Study Arms (1)
MRiS
EXPERIMENTAL* The specimens to be collected will include at least five pleural biopsy samples * MPT test and the CLDN15/VIM test will be performed
Interventions
molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms
molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any patient who is found to be unsuitable for
- surgery,
- treatment
- diagnosis,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raphael Bueno, MD
Brigham and Women's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 21, 2018
First Posted
September 25, 2018
Study Start
October 31, 2018
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
October 1, 2030
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share