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Recruiting NCT06037941

Using E-Nose Technology to Measure Response to Treatment in People With Malignant Pleural Mesothelioma

No phase Interventional Malignant Pleural Mesothelioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: E-Nose testing, Research blood.
Who it may be relevant to
Registry conditions: Malignant Pleural Mesothelioma. Basic parameters: 30 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Breathprinting (E-Nose) Technology to Measure Response to Treatment of Malignant Pleural Mesothelioma (MPM) Through MPM-Specific Volatile Organic Compounds Detected in Exhalates

Overview

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 test E-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 test Research 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.

Primary outcome measures

  • Change of MPMspecific VOCs [Time frame: up to 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 7 centers
  • Memorial Sloan Kettering Basking Ridge (Consent Only) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Consent Only) — Middletown
  • Memorial Sloan Kettering Bergen (Consent Only ) — Montvale
  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent Only) — Commack
  • Memorial Sloan Kettering Westchester (Consent Only) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (Consent Only) — Uniondale

Identifiers

NCT: NCT06037941 · 23-100

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗