Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-26 @ 1:33 PM
Study NCT ID:
NCT00639067
Status:
COMPLETED
Last Update Posted:
2014-05-16
First Post:
2008-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breath Test for Early Detection of Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-15', 'studyFirstSubmitDate': '2008-03-12', 'studyFirstSubmitQcDate': '2008-03-12', 'lastUpdatePostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer of Lung', 'Cancer of the Lung', 'Lung Cancer', 'Neoplasms, Lung', 'Neoplasms, Pulmonary', 'Pulmonary Cancer', 'Pulmonary Neoplasms'], 'conditions': ['Lung Neoplasms']}, 'referencesModule': {'references': [{'pmid': '31085817', 'type': 'DERIVED', '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.'}, {'pmid': '26698306', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate and validate a breath test for detection of early stage lung cancer that could potentially reduce number of deaths.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Group 1. Asymptomatic High Risk Subjects. Smokers aged \\>=18 undergoing chest CT\n\nGroup 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.\n\nGroup 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.\n\nGroup 4. Apparently healthy individuals having no signs and symptoms of lung carcinoma.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Group 1 - Asymptomatic High Risk Subjects\n\nInclusion criteria\n\n1. Patient is willing and able to cooperate with study and give signed informed consent to participate.\n2. Patient has had (or will have) chest imaging with spiral CT within 7 days of breath test.\n3. Age at least 18 years.\n4. History of at least 10 pack-years of cigarette smoking.\n5. Provide written informed consent prior to admission into the study.\n\nExclusion criteria\n\n1\\. Previously documented history of cancer of any site.\n\nGroup 2 - Symptomatic High Risk Subjects Without a Tissue Diagnosis\n\nInclusion criteria\n\n1. Patient is willing and able to cooperate with study and give signed informed consent to participate.\n2. Patient does not have a tissue diagnosis of pulmonary disease.\n3. 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).\n4. 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.\n\nExclusion criteria\n\n1\\. Previously documented history of cancer of any other site.\n\nGroup 3 - Symptomatic High Risk Subjects with a Tissue Diagnosis\n\nInclusion criteria\n\n1. Patient is willing and able to cooperate with study and give signed informed consent to participate.\n2. Patient has a tissue diagnosis of a. lung cancer. or b. pulmonary disease other than lung cancer e.g. sarcoidosis, COPD, or pulmonary infection.\n3. 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.\n4. Breath VOC collection will be obtained prior to any invasive procedure e.g. thoracotomy, mediastinoscopy or mediastinotomy.\n5. 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.\n\nExclusion criteria\n\n1\\. Previously documented history of cancer of any other site.\n\nGroup 4 - Apparently healthy subjects\n\nInclusion criteria\n\n1. Willingness to follow protocol requirements as evidenced by written, informed consent.\n2. Healthy, male or female subjects, ages 18 and older.\n3. Subjects who are non smokers having no signs or symptoms of lung carcinoma\n\nExclusion Criteria\n\n1\\. Any active ongoing medical problems.'}, 'identificationModule': {'nctId': 'NCT00639067', 'briefTitle': 'Breath Test for Early Detection of Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Menssana Research, Inc.'}, 'officialTitle': 'Breath Test Assay for the Adjunctive Detection of Lung Cancer', 'orgStudyIdInfo': {'id': 'M08-01'}, 'secondaryIdInfos': [{'id': '5R44HL070411-05', 'link': 'https://reporter.nih.gov/quickSearch/5R44HL070411-05', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Asymptomatic High Risk Subjects. Smokers aged \\>=18 undergoing chest CT.\n\nBreath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.', 'interventionNames': ['Device: Breath Collection Apparatus']}, {'label': '2', 'description': '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.\n\nBreath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.', 'interventionNames': ['Device: Breath Collection Apparatus']}, {'label': '3', 'description': '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.\n\nBreath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.', 'interventionNames': ['Device: Breath Collection Apparatus']}, {'label': '4', 'description': 'Apparently healthy individuals having no signs and symptoms of lung carcinoma.\n\nBreath collected using Breath Collection Apparatus and analyzed for markers of lung cancer.', 'interventionNames': ['Device: Breath Collection Apparatus']}], 'interventions': [{'name': 'Breath Collection Apparatus', 'type': 'DEVICE', 'description': 'Breath collected and analyzed for markers of lung cancer.', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Hospital', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Michael Phillips, MD, FACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Menssana Research, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menssana Research, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}