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This study is intended to determine the positive predictive value (PPV) and negative predictive value (NPV) of the multiprotein classifier based on the observed study prevalence of Non-Small Cell Lung Cancer (NSCLC) in the study participants.
Patients must present with previously non-diagnosed lung nodules as found on CT. There is no change to the typical standard of care that any of the investigating physicians and/or centers provide the patients enrolled in this study. The data from this study will not be used to diagnose cancer nor be used to influence treatment decisions for the study participants.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer | Incidence rate of Non-Small Cell Lung Cancer as determined by histologic or cytologic diagnosis and/or radiographically stability at 2 years post enrollment. | 2 years post enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Subject undergoing evaluation for a lung nodule by a pulmonologist in a pulmonary or chest clinic, and/or by a thoracic surgeon at the time of enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Russell F. Hudnall | Integrated Diagnostics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital & Medical Center | Phoenix | Arizona | 85013 | United States | ||
| Pulmonary Associates of Southern Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40296864 | Derived | Long KJ, Silvestri GA, Kammer MN, Gibbs S, Wu W, Johal M, Pipavath S, Pitcher T, Jett J, Nair VS. Validation of a High-Specificity Blood Autoantibody Test to Detect Lung Cancer in Pulmonary Nodules. CHEST Pulm. 2025 Mar;3(1):100130. doi: 10.1016/j.chpulm.2024.100130. Epub 2024 Dec 25. | |
| 29496499 | Derived | Silvestri GA, Tanner NT, Kearney P, Vachani A, Massion PP, Porter A, Springmeyer SC, Fang KC, Midthun D, Mazzone PJ; PANOPTIC Trial Team. Assessment of Plasma Proteomics Biomarker's Ability to Distinguish Benign From Malignant Lung Nodules: Results of the PANOPTIC (Pulmonary Nodule Plasma Proteomic Classifier) Trial. Chest. 2018 Sep;154(3):491-500. doi: 10.1016/j.chest.2018.02.012. Epub 2018 Mar 1. |
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Blood samples
| Tucson |
| Arizona |
| 85712 |
| United States |
| University of Southern California | Los Angeles | California | 90089 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| Georgia Lung Associates | Austell | Georgia | 30106 | United States |
| Suburban Lung Associates | Elk Grove Village | Illinois | 60007 | United States |
| Kentuckiana Pulmonary Associates | Louisville | Kentucky | 40202 | United States |
| Pulmonary & Crit Care Associates of Baltimore | Baltimore | Maryland | 21237 | United States |
| Johns Hopkins Medical Center | Baltimore | Maryland | 21287 | United States |
| Baystate Health | Springfield | Massachusetts | 01199 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Beaumont Health System | Royal Oak | Michigan | 48703 | United States |
| Virginia Piper Cancer Institute - Allina Health | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic | Rochester | Minnesota | 55901 | United States |
| St. Luke's Medical Center | Chesterfield | Missouri | 63017 | United States |
| New York University Clinical Cancer Center | New York | New York | 10016 | United States |
| Charleston Research Institute | Charleston | North Carolina | 29403 | United States |
| Carolinas HealthCare System | Charlotte | North Carolina | 28203 | United States |
| LeBaurer Healthcare | Greensboro | North Carolina | 27403 | United States |
| Salem Chest Specialists | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oregon Clinic | Portland | Oregon | 97220 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 10104 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37212 | United States |
| Scott & White Clinic | Temple | Texas | 76508 | United States |
| Inova Healthcare | Fairfax | Virginia | 22042 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| University Health Network - Toronto General Hospital | Toronto | Ontario | M5G2C4 | Canada |
| Institute Universitarie de Cardiologie et de Pneumologie | Québec | Quebec | G1V 4G5 | Canada |
| 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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