A Single-center Study to Evaluate the Feasibility of a Novel NA-NOSE for Monitoring Response to and Detecting Recurrence After Surgery or Radiation in Early Stage Lung Cancer
I. Determine if a suitable fraction of patients become NA-NOSE negative within three years
post treatment. We will test the hypothesis that this fraction is at most 30% versus the
alternative that it is at least 50%.
I. Determine if patients who become NA-NOSE negative post treatment then become NA-NOSE
positive prior to clinical recurrence.
II. Estimate the time post treatment needed to become NA-NOSE negative. III. Estimate the
lead time gained between a negative to positive NA-NOSE transition and clinical recurrence.
Patients undergo breath sample collection for the NA-NOSE breath test at baseline (2
pre-treatment samples), at 6 and 12 weeks post-treatment, and then every 3 months for up to
3 years in the absence of disease progression.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Successful evaluation of gas samples taken from lung cancer patients
Up to 3 years
Fox Chase Cancer Center
United States: Institutional Review Board
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|