Clinical trial NCT00639067: Breath Test for Early Detection of Lung Cancer
Official title: Breath Test Assay for the Adjunctive Detection of Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasms
Keywords: Cancer of Lung
Cancer of the Lung
Lung Cancer
Neoplasms, Lung
Neoplasms, Pulmonary
Pulmonary Cancer
Pulmonary Neoplasms
Lead sponsor: Menssana Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-03-19
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Sensitivity and specificity of the breath test as compared to CT and pathology to support primary lung cancer diagnosis.
timeFrame: 30 days after completion.
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Orlando
country: United States
facility: MD Anderson Cancer Center
state: Florida
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
Study officials:
affiliation: Menssana Research, Inc.
name: Michael Phillips, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.