Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-01-02 @ 7:05 AM
Study NCT ID:
NCT00899457
Status:
COMPLETED
Last Update Posted:
2014-06-24
First Post:
2009-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Markers in Predicting Lung Cancer Development Using Tissue Samples From Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001999', 'term': 'Bronchoscopy'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013510', 'term': 'Pulmonary Surgical Procedures'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-23', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collection of biological specimens to use as controls in the study of lung cancer progression', 'timeFrame': 'Off study date, up to one year', 'description': 'Specimens are collected from healthy participants with no known risk of lung cancer'}], 'secondaryOutcomes': [{'measure': 'Identification of new molecular abnormalities specific to the development of squamous cell carcinoma of the lung', 'timeFrame': 'off-study date, up to one year'}, {'measure': 'Selection of important genes/proteins differentially expressed between study groups (e.g., normal vs low-grade vs high-grade vs invasive) and between normal smokers vs normal non-smokers', 'timeFrame': 'off-study date, up to one year'}]}, 'conditionsModule': {'keywords': ['squamous cell lung cancer', 'non-small cell lung cancer', 'small cell lung cancer', 'healthy, no evidence of disease'], 'conditions': ['Healthy, no Evidence of Disease', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of blood, urine, sputum, mouth cells, and bronchial tissue from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about the development of cancer.\n\nPURPOSE: This laboratory study is looking for molecular markers in predicting lung cancer development using tissue samples from healthy participants.', 'detailedDescription': 'OBJECTIVES:\n\n* To obtain biological specimens from healthy participants with no known risk of lung cancer to use as controls in the study of lung cancer progression.\n* To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung.\n\nOUTLINE: Serum, urine, sputum, and buccal cell samples are collected. Patients also undergo bronchoscopy for collection of bronchial tissue and bronchial brush samples. The samples are used for genomic and proteomic studies to identify new molecular abnormalities specific to the development of lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy, non-smokers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Healthy participant\n\n * No history of smoking\n * No history of cancer\n\nPATIENT CHARACTERISTICS:\n\n* SWOG performance status 0\n* No clinically apparent bleeding diathesis\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00899457', 'briefTitle': 'Molecular Markers in Predicting Lung Cancer Development Using Tissue Samples From Healthy Participants', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Molecular Predictors of Lung Cancer Behavior: Controls', 'orgStudyIdInfo': {'id': 'VICC THO 0734'}, 'secondaryIdInfos': [{'id': 'P50CA090949', 'link': 'https://reporter.nih.gov/quickSearch/P50CA090949', 'type': 'NIH'}, {'id': 'P30CA068485', 'link': 'https://reporter.nih.gov/quickSearch/P30CA068485', 'type': 'NIH'}, {'id': 'VU-VICC-THO-0734'}, {'id': 'VICC-THO-0734'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy, non-smokers', 'interventionNames': ['Genetic: proteomic profiling', 'Other: biologic sample preservation procedure', 'Other: laboratory biomarker analysis', 'Procedure: bronchoscopy']}], 'interventions': [{'name': 'proteomic profiling', 'type': 'GENETIC', 'description': 'Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath', 'armGroupLabels': ['Healthy, non-smokers']}, {'name': 'biologic sample preservation procedure', 'type': 'OTHER', 'description': 'Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath', 'armGroupLabels': ['Healthy, non-smokers']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Collection of tissue, blood, urine, mouth cells, spit, nasal airway cells and breath', 'armGroupLabels': ['Healthy, non-smokers']}, {'name': 'bronchoscopy', 'type': 'PROCEDURE', 'description': 'Collection of breath condensate.', 'armGroupLabels': ['Healthy, non-smokers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37064', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center - Cool Springs', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37064', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center at Franklin', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232-6838', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Pierre P. Massion, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine (Allergy, Pulmonary & Critical Care) and Cancer Biology; Pulmonary and Critical Care Medicine Doctor', 'investigatorFullName': 'Pierre P. Massion, MD', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}