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Sponsored by: |
Menssana Research, Inc. |
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Information provided by: | Menssana Research, Inc. |
ClinicalTrials.gov Identifier: | NCT00639067 |
To demonstrate and validate a breath test for detection of early stage lung cancer that could potentially reduce number of deaths.
Condition |
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Lung Neoplasms |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Breath Test Assay for the Adjunctive Detection of Lung Cancer |
Estimated Enrollment: | 600 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Asymptomatic High Risk Subjects. Smokers aged >=18 undergoing chest CT
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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.
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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.
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4
Apparently healthy individuals having no signs and symptoms of lung carcinoma.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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.
Group 1 - Asymptomatic High Risk Subjects
Inclusion criteria
Exclusion criteria
1. Previously documented history of cancer of any site.
Group 2 - Symptomatic High Risk Subjects Without a Tissue Diagnosis
Inclusion criteria
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 has a tissue diagnosis of a. lung cancer. or b. pulmonary disease other than lung cancer e.g.
sarcoidosis, COPD, or pulmonary infection.
Exclusion criteria
1. Previously documented history of cancer of any other site.
Group 4 - Apparently healthy subjects
Inclusion criteria
Exclusion Criteria
1. Any active ongoing medical problems.
United States, Delaware | |
Christiana Hospital | Recruiting |
Newark, Delaware, United States, 19718 | |
Contact: Thomas Bauer 302-623-4530 TBauer@Christianacare.org | |
Principal Investigator: Thomas Bauer, MD | |
United States, Florida | |
MD Anderson Cancer Center | Recruiting |
Orlando, Florida, United States, 32806 | |
Contact: Alan R Forbes, MD, PhD 407-648-3800 Alan.Forbes@orhs.org | |
Principal Investigator: Alan R Forbes, MD, PhD | |
United States, New York | |
Weill Cornell Medical Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Matthew Cham, MD 212-746-6880 | |
Principal Investigator: Matthew Cham, MD | |
Sub-Investigator: David F Yankelevitz, MD | |
New York University Medical Center | Recruiting |
New York, New York, United States, 10016 | |
Contact: William N Rom, MD, MPH 212-263-6479 william.rom@med.nyu.edu | |
Principal Investigator: Harvey I Pass, MD | |
Sub-Investigator: William N Rom, MD, MPH | |
United States, Washington | |
Swedish Cancer Institute | Recruiting |
Seattle, Washington, United States, 98104 | |
Contact: Eric Vallieres, MD, FRCSC 206-215-6800 Eric.Vallieres@swedish.org | |
Principal Investigator: Eric Vallieres, MD, FRCSC |
Principal Investigator: | Michael Phillips, MD, FACP | Menssana Research, Inc. |
Responsible Party: | Menssana Research, Inc. ( Michael Phillips/Sponsor ) |
Study ID Numbers: | M01-08, NIH 5R44HL070411-05 |
Study First Received: | March 12, 2008 |
Last Updated: | July 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00639067 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cancer of Lung Cancer of the Lung Lung Cancer Neoplasms, Lung |
Neoplasms, Pulmonary Pulmonary Cancer Pulmonary Neoplasms |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases |