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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00889 | Registry Identifier | NCI, Clinical Trials Reporting Program | |
| CA152662 | Other Grant/Funding Number | National Cancer Institute (EDRN) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of sputum |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Candidate biomarkers of risk or of early diagnosis | Will validate the performance of the candidate biomarkers of risk or of early diagnosis. | Up to 5 years. |
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Inclusion Criteria:
Exclusion Criteria:
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Current or former smokers
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| Name | Affiliation | Role |
|---|---|---|
| Eric Grogan, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| ID | Term |
|---|---|
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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Sputum, nasal epithelium, buccal epithelium, blood, urine
| Biospecimen collection |
| Procedure |
Undergo collection of nasal epithelium |
|
| Biospecimen collection | Procedure | Undergo collection of buccal epithelium |
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| Biospecimen collection | Procedure | Undergo collection of blood |
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| Biospecimen collection | Procedure | Undergo collection of urine |
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| Pulmonary Function Test | Procedure | Undergo pulmonary function test |
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| Computed Tomography (CT) | Procedure | Undergo chest CT |
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| Laboratory Biomarker | Other | Correlative studies |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |