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

Sponsor
Fox Chase Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01840150
Collaborator
National Cancer Institute (NCI) (NIH)
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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
  • Procedure: breath test
  • Other: laboratory biomarker analysis
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. Determine if patients who become NA-NOSE negative post treatment then become NA-NOSE positive prior to clinical recurrence.

  2. 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

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Aug 23, 2012
Actual Primary Completion Date :
Mar 22, 2018
Anticipated Study Completion Date :
Nov 18, 2022

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Successful evaluation of gas samples taken from lung cancer patients [Up to 3 years]

  2. 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

  1. 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.

  2. Time to become nanoscale artificial nose negative post treatment [Up to 3 years]

    This will be done using the method of Kaplan and Meier.

  3. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT01840150
Other Study ID Numbers:
  • TH-040
  • NCI-2011-03308
  • IRB#11-052
  • TH-040
  • P30CA006927
First Posted:
Apr 25, 2013
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021