Study to Evaluate NA-NOSE for Monitoring and Detecting Recurrence in Early Stage Lung Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: breath test
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must either have histologic or pathologically confirmed non-small cell lung cancer (NSCLC) or suspicious nodules/lesions which are going to be surgically resected before they are pathologically confirmed Patients must have stage I or II disease based on the parameters for staging NSCLC found in the American Joint Committee on Cancer (AJCC) cancer staging handbook seventh edition Patients must be deemed to be eligible candidates for either surgery or stereotactic radiation Stereotactic radiation treatment of stage I disease or adjuvant chemotherapy is allowed at the discretion of treating physician for the participating subject Patients who will have surgical resections must consent to the use of post-surgery tumor samples for correlative molecular studies Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Ability to travel to appointments and willingness to participate in this study Ability to understand and willingness to sign a consent and Health Insurance Portability and Accountability Act (HIPAA) authorization form Exclusion Criteria: Patients who have had a prior lung cancer within the last five years from the current diagnosis Patients having a prior malignancy within the past 3 years other than resected of basal or squamous cell carcinoma of the skin, any in situ malignancy, or low-risk prostate cancer after curative therapy Patients with any prior systemic therapy for the current diagnosis of lung cancer Patients with a diagnosis of advanced stage disease (stage III or IV) Patients who are unable to comply with study and/or follow up procedures Patients who have uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements Patients who are pregnant or are breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (NA-NOSE breath test)<br>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. | Procedure: breath test<br>* Undergo NA-NOSE breath test<br>Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful evaluation of gas samples taken from lung cancer patients |  | 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. | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 3 years | 
| Time to become nanoscale artificial nose negative post treatment | This will be done using the method of Kaplan and Meier. | 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. | Up to 3 years |