Status:
COMPLETED
Study to Evaluate NA-NOSE for Monitoring and Detecting Recurrence in Early Stage Lung Cancer
Lead Sponsor:
Fox Chase Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage IA Non-small Cell Lung Cancer
Stage IB Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 l...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 23 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2019
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01840150
Start Date
August 23 2012
End Date
July 5 2019
Last Update
March 13 2023
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497