Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
215 participants
OBSERVATIONAL
2008-06-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Asymptomatic High Risk Subjects. Smokers aged \>=18 undergoing chest CT.
Breath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.
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.
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.
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.
Breath Collection Apparatus
Breath collected and analyzed for markers of lung cancer.
Interventions
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Breath Collection Apparatus
Breath collected and analyzed for markers of lung cancer.
Eligibility Criteria
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Inclusion Criteria
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.
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.
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.
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
Group 2 - Symptomatic High Risk Subjects Without a Tissue Diagnosis
1\. Previously documented history of cancer of any other site.
Group 3 - Symptomatic High Risk Subjects with a Tissue Diagnosis
1\. Previously documented history of cancer of any other site.
Group 4 - Apparently healthy subjects
1\. Any active ongoing medical problems.
18 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Menssana Research, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Phillips, MD, FACP
Role: PRINCIPAL_INVESTIGATOR
Menssana Research, Inc.
Locations
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Christiana Hospital
Newark, Delaware, United States
MD Anderson Cancer Center
Orlando, Florida, United States
New York University Medical Center
New York, New York, United States
Swedish Cancer Institute
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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M08-01
Identifier Type: -
Identifier Source: org_study_id
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