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Clinical Trial VICCTHN1291

Title

Early Diagnosis of Pulmonary Nodules Using a Plasma Proteomic Classifier

Principal Investigator(s)

Pierre Massion

Details

  • Protocol No. VICCTHN1291
  • Open Date: 03/28/2013
  • Staging: N/A
  • Age Group: Adults
  • Scope: National
  • Objective: Determine the positive predictive value (PPV) and negative predictive value (NPV) of the multi-protein classifier, e.g. lung nodule test (LNT), based on the observed study prevalence of NSCLC, for subjects with a lung nodule between 8 to 20 mm in size, except for those characterized as "pure ground glass opacity (GGO)" or "non-solid," i.e. having no solid component.
  • Disease Sites: Lung
  • Therapies: None Specified
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01752114
  • Secondary Protocol No: 1001-12

Description

The patient is being asked to participate in this research study because they have a nodule of a certain size in their lung. Researchers at Vanderbilt are conducting this study for the sponsor of the study, Integrated Diagnostics, which is the company paying for the study. The sponsor is working to demonstrate the potential of a blood test to help diagnose lung nodules by testing blood samples from participants. As part of this study we ask that patients provide blood samples collected during procedures that their doctor schedules as part of their standard of care.

Eligibility

Ages Eligible for Study:40 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers

Criteria

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