Status:
COMPLETED
Breath Test for Early Detection of Lung Cancer
Lead Sponsor:
Menssana Research, Inc.
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Lung Neoplasms
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- Group 1 - Asymptomatic High Risk Subjects
- Inclusion criteria
- Patient is willing and able to cooperate with study and give signed informed consent to participate.
- Patient has had (or will have) chest imaging with spiral CT within 7 days of breath test.
- Age at least 18 years.
- History of at least 10 pack-years of cigarette smoking.
- 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
- Patient is willing and able to cooperate with study and give signed informed consent to participate.
- Patient does not have a tissue diagnosis of pulmonary disease.
- 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).
- 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
- Patient is willing and able to cooperate with study and give signed informed consent to participate.
- Patient has a tissue diagnosis of a. lung cancer. or b. pulmonary disease other than lung cancer e.g. sarcoidosis, COPD, or pulmonary infection.
- 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.
- Breath VOC collection will be obtained prior to any invasive procedure e.g. thoracotomy, mediastinoscopy or mediastinotomy.
- 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
- Willingness to follow protocol requirements as evidenced by written, informed consent.
- Healthy, male or female subjects, ages 18 and older.
- Subjects who are non smokers having no signs or symptoms of lung carcinoma
- Exclusion Criteria
- 1\. Any active ongoing medical problems.
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT00639067
Start Date
June 1 2008
End Date
December 1 2013
Last Update
May 16 2014
Active Locations (4)
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1
Christiana Hospital
Newark, Delaware, United States, 19718
2
MD Anderson Cancer Center
Orlando, Florida, United States, 32806
3
New York University Medical Center
New York, New York, United States, 10016
4
Swedish Cancer Institute
Seattle, Washington, United States, 98104