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

Stage IIB Non-small Cell Lung Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Recurrence
• 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

• NCT number: NCT01840150
• Study type: Interventional
• Source: Fox Chase Cancer Center
• Status: Completed
• Phase: N/A
• Start date: August 23, 2012
• Completion date: July 5, 2019