Study to Evaluate NA-NOSE for Monitoring and Detecting Recurrence in Early Stage Lung Cancer
- Conditions
- Stage IB Non-small Cell Lung CancerStage IIA Non-small Cell Lung CancerStage IIB Non-small Cell Lung CancerStage IA Non-small Cell Lung Cancer
- Interventions
- Procedure: breath testOther: laboratory biomarker analysis
- Registration Number
- NCT01840150
- Lead Sponsor
- Fox Chase Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (NA-NOSE breath test) breath test 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. Treatment (NA-NOSE breath test) laboratory biomarker analysis 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States