Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03683680
Other study ID # 18-220
Secondary ID CA120528
Status Recruiting
Phase N/A
First received
Last updated
Start date October 31, 2018
Est. completion date October 1, 2025

Study information

Verified date January 2023
Source Dana-Farber Cancer Institute
Contact Raphael Bueno, MD
Phone 617-732-5690
Email rbueno@partners.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research study is evaluating a new method for determining stage and prognosis of individuals with malignant pleural mesothelioma.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date October 1, 2025
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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,

Study Design


Related Conditions & MeSH terms


Intervention

Other:
MPT Test
molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms
CLDN15/VIM Test
molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Dana-Farber Cancer Institute National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 4 years
See also
  Status Clinical Trial Phase
Recruiting NCT01950572 - Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Recruiting NCT06057935 - A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma Phase 2
Terminated NCT02838745 - Study of Cytoreductive Surgery and Hyperthermic Intraoperative Chemotherapy With Pemetrexed and Cisplatin for MPM Phase 1
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Recruiting NCT01912547 - Thromboelastography During Surgery for Malignant Pleural Mesothelioma Phase 0
Completed NCT01521325 - A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers Phase 1
Recruiting NCT02073500 - Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
Recruiting NCT00996385 - Velcade and Eloxatin for Patients With Malignant Pleural or Peritoneal Mesothelioma Phase 2
Completed NCT02467426 - Isolated Thoracic Perfusion (ITP-F) for MPM Phase 2
Completed NCT00407459 - Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma Phase 2
Completed NCT00787410 - An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma Phase 2
Terminated NCT01907100 - Nintedanib (BIBF 1120) in Mesothelioma Phase 2/Phase 3
Completed NCT04056026 - A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma Early Phase 1
Completed NCT02903914 - Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors Phase 1/Phase 2
Terminated NCT03319537 - Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma Phase 1/Phase 2
Terminated NCT03685591 - PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors Phase 1