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Spots Global Cancer Trial Database for A Multi-Center Trial of the ProLung Test™

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: A Multi-Center Trial of the ProLung Test™

Official Title: A Multi-Center Trial of the ProLung Test™ (Transthoracic Bioconductance Measurement) as an Adjunct to CT Chest Scans for the Risk Stratification of Patients With Pulmonary Lesions Suspicious for Lung Cancer

Study ID: NCT01566682

Interventions

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

UCLA Medical Center, Los Angeles, California, United States

UCSD Medical Center, San Diego, California, United States

Stanford University Medical Center, Stanford, California, United States

Loyola University Medical Center, Maywood, Illinois, United States

Greater Baltimore Medical Center, Towson, Maryland, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Henry Ford Medical Center, Detroit, Michigan, United States

University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States

Mayo Clinic, Rochester, Minnesota, United States

Wake Forest University, Winston-Salem, North Carolina, United States

Medical University of South Carolina, Charleston, South Carolina, United States

MD Anderson Cancer Center, Houston, Texas, United States

Providence Health Center, Waco, Texas, United States

Intermountain Healthcare, Murray, Utah, United States

Huntsman Cancer Institute, Salt Lake City, Utah, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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