Study to Evaluate NA-NOSE for Monitoring and Detecting Recurrence in Early Stage Lung Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
PRIMARY OBJECTIVES:
- 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:
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Determine if patients who become NA-NOSE negative post treatment then become NA-NOSE positive prior to clinical recurrence.
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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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Treatment (NA-NOSE 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. |
Procedure: breath test
Undergo NA-NOSE breath test
Other: laboratory biomarker analysis
Correlative studies
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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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
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Patients must be deemed to be eligible candidates for either surgery or stereotactic radiation
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Stereotactic radiation treatment of stage I disease or adjuvant chemotherapy is allowed at the discretion of treating physician for the participating subject
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Patients who will have surgical resections must consent to the use of post-surgery tumor samples for correlative molecular studies
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
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Ability to travel to appointments and willingness to participate in this study
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Ability to understand and willingness to sign a consent and Health Insurance Portability and Accountability Act (HIPAA) authorization form
Exclusion Criteria:
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Patients who have had a prior lung cancer within the last five years from the current diagnosis
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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
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Patients with any prior systemic therapy for the current diagnosis of lung cancer
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Patients with a diagnosis of advanced stage disease (stage III or IV)
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Patients who are unable to comply with study and/or follow up procedures
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Patients who have uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements
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Patients who are pregnant or are breast feeding
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111-2497 |
Sponsors and Collaborators
- Fox Chase Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Hossein Borghaei, Fox Chase Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TH-040
- NCI-2011-03308
- IRB#11-052
- TH-040
- P30CA006927