Early Diagnosis of Pulmonary Nodules
- Conditions
- CarcinomaPrecancerous Conditions
- Registration Number
- NCT01752114
- Lead Sponsor
- Integrated Diagnostics
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 684
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer 2 years post enrollment Incidence rate of Non-Small Cell Lung Cancer as determined by histologic or cytologic diagnosis and/or radiographically stability at 2 years post enrollment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Virginia Piper Cancer Institute - Allina Health
🇺🇸Minneapolis, Minnesota, United States
Oregon Clinic
🇺🇸Portland, Oregon, United States
New York University Clinical Cancer Center
🇺🇸New York, New York, United States
Johns Hopkins Medical Center
🇺🇸Baltimore, Maryland, United States
Beaumont Health System
🇺🇸Royal Oak, Michigan, United States
Suburban Lung Associates
🇺🇸Elk Grove Village, Illinois, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Pulmonary & Crit Care Associates of Baltimore
🇺🇸Baltimore, Maryland, United States
University Health Network - Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Pulmonary Associates of Southern Arizona
🇺🇸Tucson, Arizona, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Georgia Lung Associates
🇺🇸Austell, Georgia, United States
Charleston Research Institute
🇺🇸Charleston, North Carolina, United States
Institute Universitarie de Cardiologie et de Pneumologie
🇨🇦Quebec, Canada
St. Joseph's Hospital & Medical Center
🇺🇸Phoenix, Arizona, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Baystate Health
🇺🇸Springfield, Massachusetts, 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
Inova Healthcare
🇺🇸Fairfax, Virginia, United States
Scott & White Clinic
🇺🇸Temple, Texas, United States
LeBaurer Healthcare
🇺🇸Greensboro, North Carolina, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Kentuckiana Pulmonary Associates
🇺🇸Louisville, Kentucky, United States
Salem Chest Specialists
🇺🇸Winston-Salem, North Carolina, United States