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Study to Evaluate NA-NOSE for Monitoring and Detecting Recurrence in Early Stage Lung Cancer

Primary Purpose

Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
breath test
laboratory biomarker analysis
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stage IA Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (NA-NOSE breath test)

Arm Description

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.

Outcomes

Primary Outcome Measures

Successful evaluation of gas samples taken from lung cancer patients
Percent of patients that become nanoscale artificial nose negative within 3 years post-surgery
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
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
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
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.

Full Information

First Posted
April 23, 2013
Last Updated
March 9, 2023
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01840150
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 23, 2012 (Actual)
Primary Completion Date
March 22, 2018 (Actual)
Study Completion Date
July 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (NA-NOSE breath test)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
breath test
Intervention Description
Undergo NA-NOSE breath test
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Successful evaluation of gas samples taken from lung cancer patients
Time Frame
Up to 3 years
Title
Percent of patients that become nanoscale artificial nose negative within 3 years post-surgery
Description
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.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
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
Description
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 Frame
Up to 3 years
Title
Time to become nanoscale artificial nose negative post treatment
Description
This will be done using the method of Kaplan and Meier.
Time Frame
Up to 3 years
Title
Lead time between the transition from nanoscale artificial nose negativity to positivity and clinical recurrence
Description
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.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hossein Borghaei
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate NA-NOSE for Monitoring and Detecting Recurrence in Early Stage Lung Cancer

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