Breath Test for Early Detection of Lung Cancer

• ClinicalTrials.gov Identifier: NCT00639067
• Recruitment Status: Completed
• First Posted: March 19, 2008
• Last Update Posted: May 16, 2014
• Sponsor: Menssana Research, Inc.
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Menssana Research, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Lung Neoplasms	Device: Breath Collection Apparatus

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 Design

• Study Type: Observational
• Actual Enrollment: 215 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Breath Test Assay for the Adjunctive Detection of Lung Cancer
• Study Start Date: June 2008
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2013

Groups and Cohorts

Group/Cohort	Intervention/treatment
1; Asymptomatic High Risk Subjects. Smokers aged >=18 undergoing chest CT. Breath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.	Device: Breath Collection Apparatus; Breath collected and analyzed for markers of lung cancer.
2; 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.	Device: Breath Collection Apparatus; Breath collected and analyzed for markers of lung cancer.
3; 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.	Device: Breath Collection Apparatus; Breath collected and analyzed for markers of lung cancer.
4; Apparently healthy individuals having no signs and symptoms of lung carcinoma. Breath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.	Device: Breath Collection Apparatus; Breath collected and analyzed for markers of lung cancer.

Outcome Measures

Primary Outcome Measures :

1. Sensitivity and specificity of the breath test as compared to CT and pathology to support primary lung cancer diagnosis. [ Time Frame: 30 days after completion. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Group 1. Asymptomatic High Risk Subjects. Smokers aged >=18 undergoing chest CT

Group 2. 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.

Group 3. 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.

Group 4. Apparently healthy individuals having no signs and symptoms of lung carcinoma.

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.

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.

Contacts and Locations

Locations

United States, Delaware

Christiana Hospital

Newark, Delaware, United States, 19718

United States, Florida

MD Anderson Cancer Center

Orlando, Florida, United States, 32806

United States, New York

New York University Medical Center

New York, New York, United States, 10016

United States, Washington

Swedish Cancer Institute

Seattle, Washington, United States, 98104

Sponsors and Collaborators

Menssana Research, Inc.

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Michael Phillips, MD, FACP; Menssana Research, Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Phillips M, Bauer TL, Pass HI. A volatile biomarker in breath predicts lung cancer and pulmonary nodules. J Breath Res. 2019 Jun 19;13(3):036013. doi: 10.1088/1752-7163/ab21aa.

Phillips M, Bauer TL, Cataneo RN, Lebauer C, Mundada M, Pass HI, Ramakrishna N, Rom WN, Vallieres E. Blinded Validation of Breath Biomarkers of Lung Cancer, a Potential Ancillary to Chest CT Screening. PLoS One. 2015 Dec 23;10(12):e0142484. doi: 10.1371/journal.pone.0142484. eCollection 2015.

• Responsible Party: Menssana Research, Inc.
• ClinicalTrials.gov Identifier: NCT00639067
• Other Study ID Numbers: M08-01; 5R44HL070411-05 ( U.S. NIH Grant/Contract )
• First Posted: March 19, 2008
• Last Update Posted: May 16, 2014
• Last Verified: May 2014

Keywords provided by Menssana Research, Inc.:

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

Additional relevant MeSH terms:

Lung Neoplasms; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases