Breath Test for Early Detection of Lung Cancer

Lung Neoplasms Clinical Trial

Official title:

Breath Test Assay for the Adjunctive Detection of Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639067
• Other study ID #: M08-01
• Secondary ID: 5R44HL070411-05
• Status: Completed
• Phase: N/A
• First received: March 12, 2008
• Last updated: May 15, 2014
• Start date: June 2008
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Menssana Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Exclusion criteria

1. Previously documented history of cancer of any other site.

Group 3 - Symptomatic High Risk Subjects with a Tissue Diagnosis

Inclusion criteria

1. Patient is willing and able to cooperate with study and give signed informed consent to participate.

2. Patient has a tissue diagnosis of a. lung cancer. or b. pulmonary disease other than lung cancer e.g. sarcoidosis, COPD, or pulmonary infection.

3. A diagnosis of lung cancer is defined as cytologic or histologic confirmation of lung cancer by bronchoscopic/thoracoscopic means, sputum cytology, percutaneous fine needle aspiration biopsy. Patients may have either non-small cell lung cancer or small cell lung cancer.

4. Breath VOC collection will be obtained prior to any invasive procedure e.g. thoracotomy, mediastinoscopy or mediastinotomy.

5. 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.

Exclusion criteria

1. Previously documented history of cancer of any other site.

Group 4 - Apparently healthy subjects

Inclusion criteria

1. Willingness to follow protocol requirements as evidenced by written, informed consent.

2. Healthy, male or female subjects, ages 18 and older.

3. Subjects who are non smokers having no signs or symptoms of lung carcinoma

Exclusion Criteria

1. Any active ongoing medical problems.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Device:
• Breath Collection Apparatus
Breath collected and analyzed for markers of lung cancer.

Locations

Country	Name	City	State
United States	New York University Medical Center	New York	New York
United States	Christiana Hospital	Newark	Delaware
United States	MD Anderson Cancer Center	Orlando	Florida
United States	Swedish Cancer Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Menssana Research, Inc.	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of the breath test as compared to CT and pathology to support primary lung cancer diagnosis.		30 days after completion.	No