Malignant Pleural Mesothelioma
Conditions
Keywords
Breathprinting (E-Nose) Technology, MPM-Specific Volatile Organic Compounds, 23-100
Brief summary
The researchers are doing this study to test the ability of a new technology called breathprinting, or electronic nose (E-Nose), to measure how people respond to standard treatment for malignant pleural mesothelioma (MPM). The researchers will study how E-Nose breathprints change over time as people receive standard treatment for MPM. They will also look at how changes in people's E-Nose breathprints compare to changes in their standard imaging scans and in biomarkers of MPM in their blood.
Interventions
DIAGNOSTIC_TESTE-Nose testing
At baseline (before any treatment is administered) approximately when the patient is scheduled for a CT of the Chest and/or PET/CT after initiation of any treatment, as medically permissible and at the PI's discretion. A breath sample from each patient will be captured in a cartridge, which will form the basis for the E-Nose analysis, to be performed by study investigators at UCB.
DIAGNOSTIC_TESTResearch blood
Research blood tests will be obtained at baseline and the first three standard of care follow up visits, scheduled by their treating physician along with a CT of the Chest and/or PET/CT1 to determine whether serum biomarkers of MPM.
Sponsors
UNIVERSITY CAMPUS BIO-MEDICO, ITALY
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Aged 30-85 years * No history of thoracic cancer or extrathoracic cancer potentially involving pleural metastases (i.e., breast, gastric, colon, or pancreas cancer) * Recent diagnosis of MPM * Documented, signed, and dated informed consent, obtained before any procedures, for the proposed research study, and signed standard surgical consent for surgical resection
Exclusion criteria
* Aged \<30 or \>85 years at the first outpatient visit * History of thoracic or extrathoracic cancer that puts the subject at risk for pleural or pulmonary metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of MPMspecific VOCs | up to 1 year | compared with imaging (using RECIST 1.1 and mRECIST). |
Countries
United States
Contacts
Primary ContactGaetano Rocco, MD
Backup ContactDavid Jones, MD
Outcome results
None listed