This clinical trial studies nanoscale artificial nose (NA-NOSE) in monitoring response and detecting recurrence after surgery or radiation therapy in patients with stage I or stage II non-small cell lung cancer (NSCLC). Using the NA-NOSE breath test may be an effective way to monitor response and detect recurrence of NSCLC after surgery or radiation therapy.
PRIMARY OBJECTIVES: 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%. SECONDARY OBJECTIVES: 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. OUTLINE: Patients undergo breath sample collection for the NA-NOSE breath test at baseline (2 pre-treatment samples), and post treatment samples at regularly scheduled follow up visits, for 2 years in the absence of disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
41
Undergo NA-NOSE breath test
Correlative studies
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Successful evaluation of gas samples taken from lung cancer patients
Time frame: Up to 3 years
Percent of patients that become nanoscale artificial nose negative within 3 years post-surgery
We will test the null hypothesis that at most 30% of patients will become nanoscale artificial nose negative within 3 years post- surgery. The alternative will be that this fraction will be at least 50%. If at least 15/35 patients become nanoscale artificial nose negative within 3 years post treatment follow up we will reject the null. The test has 84.5% power and 7.31% type I error.
Time frame: Up to 3 years
Percentage of patients who become nanoscale artificial nose negative within 3 years and recur within that time frame that will become nanoscale artificial nose positive before recurrence
We will test the hypothesis that at most 25% of patients who become nanoscale artificial nose negative within 3 years and recur within that time frame will become nanoscale artificial nose positive before recurrence. The alternative is that at least 50% of such patients will become nanoscale artificial nose positive before recurrence.
Time frame: Up to 3 years
Time to become nanoscale artificial nose negative post treatment
This will be done using the method of Kaplan and Meier.
Time frame: Up to 3 years
Lead time between the transition from nanoscale artificial nose negativity to positivity and clinical recurrence
We will restrict this estimate to data from patients who experience a transition and will use the method of Kaplan and Meier. We will tabulate frequencies of patients who recur with or without such a transition as well as those for patients who never become nanoscale artificial nose negative.
Time frame: Up to 3 years
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