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| ID | Type | Description | Link |
|---|---|---|---|
| 1RC2CA148572-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to determine the validity of a multi-gene Lung Cancer Risk Test (LCRT). In the process, the investigators will establish a bank of NBEC samples and corresponding blood samples from individuals demographically at increased risk for lung cancer.
Because more than 160,000 individuals die of lung cancer/year in the United States alone, it is important to use the best possible methods to determine whether increased surveillance of individuals at highest risk for lung cancer will result in reduced lung cancer mortality. The Lung Cancer Risk Test (LCRT) proposed for evaluation promises to accurately identify the 10-15% of the population that is most susceptible to lung cancer based on genetic predisposition. More than 90 million individuals in the United States alone are demographically at high risk for lung cancer and potential candidates for increased surveillance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Lung Cancer, Heavy Smoker | Subjects will be ≥ 50 years of age and have a ≥ 20 pack year smoking history and will be either healthy volunteers or individuals undergoing diagnostic bronchoscopy, with absence of lung cancer documented at the time of enrollment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung Cancer Risk Test | Genetic | Measurement of gene expression in normal bronchial epithelial cells obtained at time of bronchoscopy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of LCRT to predict incidental lung cancer | Time of diagnosis of incidental lung cancer will be compared to value of the investigational device, the Lung Cancer Risk Test (LCRT). | from time of enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of subjects aged 50 to 90 and with 20 or more pack year smoking history, who are determined not to have lung cancer at the time of enrollment or within three months after the date of enrollment, and either a) volunteer for the study driven bronchoscopy, or b) have standard of care clinical need for diagnostic bronchoscopy (e.g. they may present with respiratory symptoms or abnormal test results consistent with the need for bronchoscopy).
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| Name | Affiliation | Role |
|---|---|---|
| James Willey, MD | University of Toledo Health Science Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26801409 | Background | Crawford EL, Levin A, Safi F, Lu M, Baugh A, Zhang X, Yeo J, Khuder SA, Boulos AM, Nana-Sinkam P, Massion PP, Arenberg DA, Midthun D, Mazzone PJ, Nathan SD, Wainz R, Silvestri G, Tita J, Willey JC. Lung cancer risk test trial: study design, participant baseline characteristics, bronchoscopy safety, and establishment of a biospecimen repository. BMC Pulm Med. 2016 Jan 22;16:16. doi: 10.1186/s12890-016-0178-4. |
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Normal bronchial epithelial cell (NBEC) RNA. NBEC samples were obtained by bronchoscopic brushing after informed consent to this project was obtained. RNA was extracted and frozen in aliquots then archived. Two aliquots, were prepared for most subjects. In most cases, there were more than 1 microgram of RNA per aliquot.
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| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Henry Ford | Detroit | Michigan | 48202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43221 | United States |
| The Toledo Hospital | Toledo | Ohio | 43606 | United States |
| Mercy St. Vincent Medical Center | Toledo | Ohio | 43608 | United States |
| University of Toledo, Health Science Campus | Toledo | Ohio | 43614 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Tennessee Valley Veterans Admin. | Nashville | Tennessee | 37232 | United States |
| Vanderbilt | Nashville | Tennessee | 37232 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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