study to evaluate na-nose for monitoring and detecting recurrence 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

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.

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.

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