Breath Test for Early Detection of Lung Cancer

Breath Test Assay for the Adjunctive Detection of Lung Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00639067

Enrollment

215

Registered

2008-03-19

Start date

2008-06-30

Completion date

2013-12-31

Last updated

2014-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms

Keywords

Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms

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.

Interventions

DEVICEBreath Collection Apparatus

Breath collected and analyzed for markers of lung cancer.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Group 1 - Asymptomatic High Risk Subjects Inclusion criteria 1. Patient is willing and able to cooperate with study and give signed informed consent to participate. 2. Patient has had (or will have) chest imaging with spiral CT within 7 days of breath test. 3. Age at least 18 years. 4. History of at least 10 pack-years of cigarette smoking. 5. Provide written informed consent prior to admission into the study.

Exclusion criteria

1\. Previously documented history of cancer of any site. Group 2 - Symptomatic High Risk Subjects Without a Tissue Diagnosis Inclusion criteria 1. Patient is willing and able to cooperate with study and give signed informed consent to participate. 2. Patient does not have a tissue diagnosis of pulmonary disease. 3. Patient is undergoing evaluation for an unexplained pulmonary illness which is clinically consistent with lung cancer. This includes patients with unexplained symptoms (e.g. chronic unexplained cough or hemoptysis), unexplained signs (e.g. weight loss, lymphadenopathy) or unexplained investigations (e.g. an abnormal chest x-ray). 4. Actively smoking patients, as well as never smokers and former smokers are eligible for the study so long as a complete smoking consumption history can be recorded.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026