Tumor Heterogeneity of the Tumor Microenvironment in Malignant Pleural Mesothelioma (MPM)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-006443
Sponsor Protocol Number: 17-006443
About this study
The purpose of this study is to:
-
Evaluate MPM tumor heterogeneity by determining the agreement of histology, molecular abnormalities, neo-antigen expression and immunological biomarkers between three tumor samples from MPM patients.
- Compare the information from tumor samples to pleural fluid, peripheral blood and density based radiomics analysis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Subject provides informed consent
- Subject is >18 years of age
- Subject is deemed competent for making medical decisions
- Subjects with MPM and pleural effusion who are treatment naïve
- Subject is scheduled to undergo pleuroscopy, mediastinoscopy, thoracotomy, or laparascopy as part of their standard care for MPM.
- A negative pregnancy test is required in women of child-bearing potential, as standard of care.
- Subject is mentally capable of understanding study procedures.
Exclusion Criteria
- Study subject has any disease or condition that interferes with safe completion of the study including:
- Platelet count < 50K, coagulopathy defined as an International Normalized Ratio (INR) > 1.5
- Anticoagulants such as clopidogrel, heparin, low-molecular weight heparin, warfarin or other novel anticoagulants have not been held for the standard time period published.
- Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians.
- Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians
- Concurrent participation in another study involving investigational drugs or investigational medical devices
- Absence of or limited access to the pleural space during pleuroscopy.
- Inability to read and understand the necessary study documents.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available