Early Diagnosis of Pulmonary Nodules

Completed

Conditions studied: Precancerous Conditions, Carcinoma

In brief

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.

Key facts

Study ID

NCT01752114

Run by

Integrated Diagnostics

People needed

684

Starts

2012-10-01

Expected to finish

2016-12-31

Last updated by the study team

2018-03-01

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States
• Pulmonary Associates of Southern Arizona — Tucson, Arizona, United States
• University of Southern California — Los Angeles, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Georgia Lung Associates — Austell, Georgia, United States
• Suburban Lung Associates — Elk Grove Village, Illinois, United States
• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• Pulmonary & Crit Care Associates of Baltimore — Baltimore, Maryland, United States
• Johns Hopkins Medical Center — Baltimore, Maryland, United States
• Baystate Health — Springfield, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Beaumont Health System — Royal Oak, Michigan, United States
• Virginia Piper Cancer Institute - Allina Health — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• St. Luke's Medical Center — Chesterfield, Missouri, United States
• New York University Clinical Cancer Center — New York, New York, United States
• Charleston Research Institute — Charleston, North Carolina, United States
• Carolinas HealthCare System — Charlotte, North Carolina, United States
• LeBaurer Healthcare — Greensboro, North Carolina, United States
• Salem Chest Specialists — Winston-Salem, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oregon Clinic — Portland, Oregon, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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