A Multi-Center Trial of the ProLung Test™

Summary

The primary Study hypothesis is that the ProLung Test will demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer. A statistically significant result will indicate that patients with a high ProLung Test result have a greater risk of developing lung cancer than patients with a low test result.

There are three Specific Aims of this study:

1. Optimize and confirm the stability of the ProLung Test risk-stratification algorithm in patients with a diagnosis.
2. Externally validate the efficacy of the ProLung Test risk-stratification algorithm by comparing the test result to the conclusive patient diagnosis.
3. Assess the safety and tolerability of the ProLung Test procedures.

Study Design This Study consists of two distinct phases, Stabilization and Validation. The Study will collect data from multiple sites (3 to 12), and each site may enroll patients and collect data for the Stabilization and Validation Phases with a minimum of three sites for the Validation Phase.

Conditions

• Solitary Pulmonary Nodule
• Multiple Pulmonary Nodules

Sponsors & Collaborators

• Huntsman Cancer Institute

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• Henry Ford Health System

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Intermountain Health Care, Inc.

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• Greater Baltimore Medical Center

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Loyola University

  collaborator OTHER

• Providence Health Center

  collaborator UNKNOWN

• Wake Forest

  collaborator UNKNOWN

• University of Minnesota Masonic Cancer Center

  collaborator UNKNOWN

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Fresh Medical Laboratories

  lead INDUSTRY

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2019-03-31

Completion

2019-03-31

Countries

• United States

Study Locations