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
Conditions
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.
Interventions
PROCEDUREbreath test
Undergo NA-NOSE breath test
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Fox Chase Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 3 years | 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 to become nanoscale artificial nose negative post treatment | Up to 3 years | This will be done using the method of Kaplan and Meier. |
| Lead time between the transition from nanoscale artificial nose negativity to positivity and clinical recurrence | Up to 3 years | 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. |
Countries
United States
Outcome results
None listed