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

NCT01840150 | Completed

• 4 other identifiers: TH-040NCI-2011-03308IRB#11-052P30CA006927
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Successful evaluation of gas samples taken from lung cancer patients

  Up to 3 years

• 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.

  Up to 3 years

Secondary Outcomes (3)

• 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

• Time to become nanoscale artificial nose negative post treatment

  Up to 3 years

• Lead time between the transition from nanoscale artificial nose negativity to positivity and clinical recurrence

  Up to 3 years

Study Arms (1)

Treatment (NA-NOSE breath test)

EXPERIMENTAL

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; Other: laboratory biomarker analysis

Interventions

breath test PROCEDURE

Undergo NA-NOSE breath test

Treatment (NA-NOSE breath test)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (NA-NOSE breath test)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hossein Borghaei

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 25, 2013
• Study Start: August 23, 2012
• Primary Completion: March 22, 2018
• Study Completion: July 5, 2019
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

US (1)