Breath Test for Early Detection of Lung Cancer

Completed

• Conditions: Lung Neoplasms
• Interventions: Device: Breath Collection Apparatus

• Registration Number: NCT00639067
• Lead Sponsor: Menssana Research, Inc.

Brief Summary

To demonstrate and validate a breath test for detection of early stage lung cancer that could potentially reduce number of deaths.

Detailed Description

This is a multicenter study comparing several groups of subjects with and without lung cancer by CT scan, biopsy and the breath test. The breath test will be performed to validate the methodology and the predictive algorithm that were previously developed.

Study Timeline

• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-19
• Study Start: 2008-06
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-15
• Last Update Posted: 2014-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Breath Collection Apparatus	Asymptomatic High Risk Subjects. Smokers aged \>=18 undergoing chest CT. Breath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.
2	Breath Collection Apparatus	Symptomatic High Risk Subjects Without a Tissue Diagnosis. This group will comprise patients who are undergoing medical evaluation for a pulmonary symptom such as chronic unexplained cough or hemoptysis. Breath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.
3	Breath Collection Apparatus	Symptomatic High Risk Subjects With a Tissue Diagnosis. This group will be found to include a. lung cancer, and b. diseases other than lung cancer e.g. sarcoidosis, COPD or pulmonary infection. Breath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.
4	Breath Collection Apparatus	Apparently healthy individuals having no signs and symptoms of lung carcinoma. Breath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the breath test as compared to CT and pathology to support primary lung cancer diagnosis.	30 days after completion.

Trial Locations

Locations (4)

Christiana Hospital; 🇺🇸 Newark, Delaware, United States

MD Anderson Cancer Center; 🇺🇸 Orlando, Florida, United States

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States

New York University Medical Center; 🇺🇸 New York, New York, United States