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

Primary Purpose

Mesothelioma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MPT Test
CLDN15/VIM Test
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mesothelioma focused on measuring Mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRiS

Arm Description

The specimens to be collected will include at least five pleural biopsy samples MPT test and the CLDN15/VIM test will be performed

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.

Full Information

First Posted
September 21, 2018
Last Updated
January 23, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03683680
Brief Title
Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers
Official Title
Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2018 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma
Keywords
Mesothelioma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRiS
Arm Type
Experimental
Arm Description
The specimens to be collected will include at least five pleural biopsy samples MPT test and the CLDN15/VIM test will be performed
Intervention Type
Other
Intervention Name(s)
MPT Test
Intervention Description
molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms
Intervention Type
Other
Intervention Name(s)
CLDN15/VIM Test
Intervention Description
molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms
Primary Outcome Measure Information:
Title
Pre-treatment Prognostic Algorithm Validation
Description
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 Outcome Measure Information:
Title
Evaluation of Molecular Tests Base on RNA Expression
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raphael Bueno, MD
Phone
617-732-5690
Email
rbueno@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael Bueno, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphael Bueno, MD
Phone
617-732-5690
Email
rbueno@partners.org
First Name & Middle Initial & Last Name & Degree
Raphael Bueno, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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