Nanoscale Artificial 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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Fox Chase Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT01840150
First received: April 23, 2013
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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 Intervention
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
Procedure: breath test
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Successful evaluation of gas samples taken from lung cancer patients [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Percent of patients that become nanoscale artificial nose negative within 3 years post-surgery [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 35
Study Start Date: August 2012
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840150

Locations
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Hossein Borghaei    215-214-4298    hossein.borghaei@fccc.edu   
Principal Investigator: Hossein Borghaei         
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Principal Investigator: Hossein Borghaei Fox Chase Cancer Center
  More Information

No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT01840150     History of Changes
Other Study ID Numbers: TH-040, NCI-2011-03308, IRB#11-052, TH-040, P30CA006927
Study First Received: April 23, 2013
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Recurrence
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014