Lung Cancer Clinical Trial
Study to Evaluate NA-NOSE for Monitoring and Detecting Recurrence in Early Stage 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.
Full 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.
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
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There is 1 Location for this study
Philadelphia Pennsylvania, 19111, United States
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