Carcinoma Clinical Trial
Official title:
Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12
Verified date | August 2016 |
Source | Integrated Diagnostics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 684 |
Est. completion date | December 31, 2016 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Age = 40 years - Smoking history: Never, Former, Current - Subject undergoing diagnostic evaluation for a lung nodule - Subject undergoing evaluation for a lung nodule by a pulmonologist, and/or by a thoracic surgeon - Baseline CT scan identifying lung nodule performed within 60 days of subject enrollment - Nodule(s) identified by CT scan previously not followed - Subject willing to provide informed consent for the collection of blood specimens Exclusion Criteria: - Nodule work-up at the time of enrollment eligibility indicates any prior attempted or completed diagnostic biopsy procedure, such as transthoracic needle aspiration, bronchoscopic biopsy or surgery - A prior CT scan is available that previously identifies the same lung nodule under consideration for study inclusion on the most current CT scan; AND the prior CT scan was performed more than 60 days before the current CT scan, irrespective of the candidate nodule's radiographic characterization such as size, density or appearance - Current diagnosis of any cancer - Prior diagnosis of any cancer within 2 years of lung nodule detection, except for non-melanoma skin cancer - Administration of blood products, e.g. packed red blood cells, fresh frozen plasma, or platelets, within 30 days of subject enrollment - History of human immunodeficiency virus (HIV) or Hepatitis C |
Country | Name | City | State |
---|---|---|---|
Canada | Institute Universitarie de Cardiologie et de Pneumologie | Quebec | |
Canada | University Health Network - Toronto General Hospital | Toronto | Ontario |
United States | Georgia Lung Associates | Austell | Georgia |
United States | Johns Hopkins Medical Center | Baltimore | Maryland |
United States | Pulmonary & Crit Care Associates of Baltimore | Baltimore | Maryland |
United States | Charleston Research Institute | Charleston | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Carolinas HealthCare System | Charlotte | North Carolina |
United States | St. Luke's Medical Center | Chesterfield | Missouri |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Suburban Lung Associates | Elk Grove Village | Illinois |
United States | Inova Healthcare | Fairfax | Virginia |
United States | LeBaurer Healthcare | Greensboro | North Carolina |
United States | University of Southern California | Los Angeles | California |
United States | Kentuckiana Pulmonary Associates | Louisville | Kentucky |
United States | Virginia Piper Cancer Institute - Allina Health | Minneapolis | Minnesota |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | New York University Clinical Cancer Center | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | St. Joseph's Hospital & Medical Center | Phoenix | Arizona |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | Oregon Clinic | Portland | Oregon |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Beaumont Health System | Royal Oak | Michigan |
United States | California Pacific Medical Center | San Francisco | California |
United States | Sarasota Memorial Hospital | Sarasota | Florida |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Baystate Health | Springfield | Massachusetts |
United States | Scott & White Clinic | Temple | Texas |
United States | Pulmonary Associates of Southern Arizona | Tucson | Arizona |
United States | Salem Chest Specialists | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Integrated Diagnostics |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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