CompletedNot applicableNCT01752114

Early Diagnosis of Pulmonary Nodules

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.

Checked against the public recordLast updated Mar 1, 2018 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations33
SponsorIntegrated Diagnostics
01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Integrated Diagnostics
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • St. Joseph's Hospital & Medical CenterPhoenix, Arizona
  • Pulmonary Associates of Southern ArizonaTucson, Arizona
  • University of Southern CaliforniaLos Angeles, California
  • California Pacific Medical CenterSan Francisco, California
  • Sarasota Memorial HospitalSarasota, Florida
  • Georgia Lung AssociatesAustell, Georgia
  • Suburban Lung AssociatesElk Grove Village, Illinois
  • Kentuckiana Pulmonary AssociatesLouisville, Kentucky
  • Pulmonary & Crit Care Associates of BaltimoreBaltimore, Maryland
  • Johns Hopkins Medical CenterBaltimore, Maryland
  • Baystate HealthSpringfield, Massachusetts
  • Henry Ford HospitalDetroit, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 1, 2018. Always confirm current availability with the study team.

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