MesotheliomaNCT03683680
Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers
A study testing MPT Test and CLDN15/VIM Test in people with Mesothelioma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is evaluating a new method for determining stage and prognosis of individuals with malignant pleural mesothelioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma
- What is being tested?
- MPT Test and CLDN15/VIM Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2018to 1 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -Any patient who is found to be unsuitable for
- surgery,
- treatment
- diagnosis,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Raphael Bueno, MD, 617-732-5690, rbueno@partners.org
Raphael Bueno, MD
About this study
This research study is evaluating a new method for determining stage and prognosis of individuals with malignant pleural mesothelioma.
Read the 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
- Conditions
- Mesothelioma
- Being tested
- MPT Test, CLDN15/VIM Test
- Keywords
- Mesothelioma
- Medical subject headings
- Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPT TestOther
molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms
CLDN15/VIM TestOther
molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: MPT Test; Other: CLDN15/VIM Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start31 Oct 2018
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Raphael Bueno, MD, Dana-Farber Cancer Institute
- Investigators
- Raphael Bueno, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683680
- Sponsor's protocol ID
- 18-220
- Other IDs
- CA120528
- Status last verified
- Apr 2026
- First submitted
- 21 Sep 2018
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospectively Collected Pleural Biopsies for Validation of Malignant Pleural Mesothelioma Prognostic Biomarkers
- ClinicalTrials.gov ID
- NCT03683680
- Acronym / sponsor ID
- 18-220
- Conditions
- Mesothelioma
- Keywords
- Mesothelioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRiS | Experimental | Other: MPT Test, Other: CLDN15/VIM Test* The specimens to be collected will include at least five pleural biopsy samples * MPT test and the CLDN15/VIM test will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All adult patients with a diagnosis of malignant pleural mesothelioma undergoing
- Participants must be 18 years of age or older.
Key exclusion criteria (4 listed)
- -Any patient who is found to be unsuitable for
- surgery,
- treatment
- diagnosis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPT Testmolecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms | Other | MRiS |
| CLDN15/VIM Testmolecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms | Other | MRiS |
Primary outcome
Pre-treatment Prognostic Algorithm Validation
Time frame: 4 years
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
1 secondary outcome
Evaluation of Molecular Tests Base on RNA Expression
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
Related trials for Mesothelioma
RecruitingPhase 1
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Mesothelioma, Neoplasms
RecruitingObservational study
Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Thymoma, Stomach Neoplasms
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 1/2
A 2-part Phase 1/2 Open-label Trial on ODM-212
Mesothelioma, Pancreatic Cancer
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raphael Bueno, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPT Test and CLDN15/VIM Test in people with Mesothelioma, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raphael Bueno, MD (617-732-5690, rbueno@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-treatment Prognostic Algorithm Validation (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.