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The primary objective is to identify a panel of plasma and/or serum proteins that differentiates the absence or presence of lung malignancy in samples obtained from subjects enrolled in this IRB/EC approved study with pulmonary nodules.
Blood samples are obtained from those patients undergoing procedures to determine if a lung nodule is benign or cancerous. The data from the study will not be used to guide or influence the treatment of the patients enrolled in this study. There is no change from the normal standard of care that patients receive.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of Non-Small Cell Lung Cancer | The incidence rate of non-small cell lung cancer in the study population will be correlated to the predictive value of the Sponsor's blood test. | 24 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Panel of proteins | The positive and negative predictive value of the test to differentiate between malignancy and inflammatory diseases such as granulomatous disorders. | At the end of the study |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing procedure for histologic diagnosis of lung nodule(s)
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| Name | Affiliation | Role |
|---|---|---|
| Russell F. Hudnall | Integrated Diagnostics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California | San Francisco | California | 94115 | United States | ||
| University of Miami - Sylvester Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28545097 | Derived | Kearney P, Hunsucker SW, Li XJ, Porter A, Springmeyer S, Mazzone P. An integrated risk predictor for pulmonary nodules. PLoS One. 2017 May 17;12(5):e0177635. doi: 10.1371/journal.pone.0177635. eCollection 2017. | |
| 26376647 | Derived | Vachani A, Hammoud Z, Springmeyer S, Cohen N, Nguyen D, Williamson C, Starnes S, Hunsucker S, Law S, Li XJ, Porter A, Kearney P. Clinical Utility of a Plasma Protein Classifier for Indeterminate Lung Nodules. Lung. 2015 Dec;193(6):1023-7. doi: 10.1007/s00408-015-9800-0. Epub 2015 Sep 16. |
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| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Blood samples
| Miami |
| Florida |
| 33136 |
| United States |
| North East Alabama Regional Medical Center | Anniston | Georgia | 36207 | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55901 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Cardiopulmonary Research Science and Technology Institute | Dallas | Texas | 75230 | United States |
| Intermountain Healthcare | Murray | Utah | 84107 | United States |
| Group Health Research Institute | Seattle | Washington | 98101 | United States |