About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
E-Nose testing
Diagnostic testAt 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.
Research blood
Diagnostic testResearch 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.
Treatment groups
Trial outcomes
Primary outcomes
Change of MPMspecific VOCs
compared with imaging (using RECIST 1.1 and mRECIST).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
UNIVERSITY CAMPUS BIO-MEDICO, ITALY
Collaborator