Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT03181256
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2017-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}], 'ancestors': [{'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Sputum, nasal epithelium, buccal epithelium, blood, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2017-06-06', 'studyFirstSubmitQcDate': '2017-06-06', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Candidate biomarkers of risk or of early diagnosis', 'timeFrame': 'Up to 5 years.', 'description': 'Will validate the performance of the candidate biomarkers of risk or of early diagnosis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This research trial studies the long term follow-up for early detection of lung cancer in current or former smokers. Following up on smokers by collecting and analyzing specimens in the laboratory, performing chest computed tomography (CT) scans, as well as reviewing medical records may help doctors detect lung cancer at an earlier stage.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To provide screening for lung cancer in an underserved and high risk population for lung cancer.\n\nII. To collect clinical and demographic information and research bio specimens prospectively on high risk individuals.\n\nIII. To analyze the association between suspected lung cancer risk factors and outcomes such as pre-malignant lesions and diagnosis of lung cancer.\n\nIV. To identify and validate biomarkers that are associated with lung cancer risk factors and premalignant lesions.\n\nV. To assess the association between patient characteristics and test results to the genetic and histological characteristics of lung preinvasive lesions and cancers.\n\nVI. To describe this high-risk cohort and to identify the patients eligible for future clinical trials (e.g. chemoprevention).\n\nOUTLINE:\n\nPatients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. Patients also undergo pulmonary function tests, chest CT, and review of medical records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Current or former smokers', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current smoker or former smoker, if former smoker participants must have quit smoking within the past 15 years\n* \\>= 30 pack year of smoking history\n* Participant is uninsured\n\nExclusion Criteria:\n\n* History of diagnosis/treatment of lung cancer in the past 2 years\n* History of head/neck or esophageal cancer in the last 1 year\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03181256', 'briefTitle': 'Early Detection of Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Early Detection of Lung Cancer in the Medically Underserved Population', 'orgStudyIdInfo': {'id': 'VICC THO 1730'}, 'secondaryIdInfos': [{'id': 'NCI-2017-00889', 'type': 'REGISTRY', 'domain': 'NCI, Clinical Trials Reporting Program'}, {'id': 'CA152662', 'type': 'OTHER_GRANT', 'domain': 'National Cancer Institute (EDRN)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Screening', 'description': 'Patients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. Patients also undergo pulmonary function tests, chest CT, and review of medical records', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Pulmonary Function Test', 'Procedure: Computed Tomography (CT)', 'Other: Laboratory Biomarker']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'description': 'Undergo collection of sputum', 'armGroupLabels': ['Screening']}, {'name': 'Biospecimen collection', 'type': 'PROCEDURE', 'description': 'Undergo collection of nasal epithelium', 'armGroupLabels': ['Screening']}, {'name': 'Biospecimen collection', 'type': 'PROCEDURE', 'description': 'Undergo collection of buccal epithelium', 'armGroupLabels': ['Screening']}, {'name': 'Biospecimen collection', 'type': 'PROCEDURE', 'description': 'Undergo collection of blood', 'armGroupLabels': ['Screening']}, {'name': 'Biospecimen collection', 'type': 'PROCEDURE', 'description': 'Undergo collection of urine', 'armGroupLabels': ['Screening']}, {'name': 'Pulmonary Function Test', 'type': 'PROCEDURE', 'description': 'Undergo pulmonary function test', 'armGroupLabels': ['Screening']}, {'name': 'Computed Tomography (CT)', 'type': 'PROCEDURE', 'otherNames': ['Undergo chest CT'], 'description': 'Undergo chest CT', 'armGroupLabels': ['Screening']}, {'name': 'Laboratory Biomarker', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Eric Grogan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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 Thoracic Surgery', 'investigatorFullName': 'Eric Grogan', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}