Clinical trial NCT01840150: Study to Evaluate NA-NOSE for Monitoring and Detecting Recurrence in Early Stage Lung Cancer
Official title: A Single-center Study to Evaluate the Feasibility of a Novel NA-NOSE for Monitoring Response to and Detecting Recurrence After Surgery or Radiation in Early Stage Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-04-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Successful evaluation of gas samples taken from lung cancer patients
timeFrame: Up to 3 years
measure: Percent of patients that become nanoscale artificial nose negative within 3 years post-surgery
timeFrame: Up to 3 years
Secondary outcomes:
measure: 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
timeFrame: Up to 3 years
measure: Time to become nanoscale artificial nose negative post treatment
timeFrame: Up to 3 years
measure: Lead time between the transition from nanoscale artificial nose negativity to positivity and clinical recurrence
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Hossein Borghaei
role: PRINCIPAL_INVESTIGATOR
References: