Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
45 participants
OBSERVATIONAL
2017-12-14
2025-12-01
Brief Summary
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Detailed Description
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I. To provide screening for lung cancer in an underserved and high risk population for lung cancer.
II. To collect clinical and demographic information and research bio specimens prospectively on high risk individuals.
III. To analyze the association between suspected lung cancer risk factors and outcomes such as pre-malignant lesions and diagnosis of lung cancer.
IV. To identify and validate biomarkers that are associated with lung cancer risk factors and premalignant lesions.
V. To assess the association between patient characteristics and test results to the genetic and histological characteristics of lung preinvasive lesions and cancers.
VI. To describe this high-risk cohort and to identify the patients eligible for future clinical trials (e.g. chemoprevention).
OUTLINE:
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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Screening
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
Biospecimen Collection
Undergo collection of sputum
Biospecimen collection
Undergo collection of nasal epithelium
Biospecimen collection
Undergo collection of buccal epithelium
Biospecimen collection
Undergo collection of blood
Biospecimen collection
Undergo collection of urine
Pulmonary Function Test
Undergo pulmonary function test
Computed Tomography (CT)
Undergo chest CT
Laboratory Biomarker
Correlative studies
Interventions
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Biospecimen Collection
Undergo collection of sputum
Biospecimen collection
Undergo collection of nasal epithelium
Biospecimen collection
Undergo collection of buccal epithelium
Biospecimen collection
Undergo collection of blood
Biospecimen collection
Undergo collection of urine
Pulmonary Function Test
Undergo pulmonary function test
Computed Tomography (CT)
Undergo chest CT
Laboratory Biomarker
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \>= 30 pack year of smoking history
* Participant is uninsured
Exclusion Criteria
* History of head/neck or esophageal cancer in the last 1 year
* Inability to provide informed consent
55 Years
80 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Eric Grogan
Associate Professor of Thoracic Surgery
Principal Investigators
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Eric Grogan, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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NCI-2017-00889
Identifier Type: REGISTRY
Identifier Source: secondary_id
CA152662
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
VICC THO 1730
Identifier Type: -
Identifier Source: org_study_id
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