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Completed No phase listed Observational Results available

A Multi-Center Trial of the ProLung Test™

ClinicalTrials.gov ID: NCT01566682

Public ClinicalTrials.gov record NCT01566682. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 10:10 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01566682
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Fresh Medical Laboratories
Industry
Enrollment
420 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2012
Primary completion
Feb 28, 2019
Completion
Feb 28, 2019
Last update posted
Sep 3, 2019

2012 – 2019

United States locations

U.S. sites
15
U.S. states
10
U.S. cities
15
Facility City State ZIP Site status
UCLA Medical Center Los Angeles California 90024
UCSD Medical Center San Diego California 92103
Stanford University Medical Center Stanford California 94305
Loyola University Medical Center Maywood Illinois 60153
Greater Baltimore Medical Center Towson Maryland 21204
Beth Israel Deaconess Medical Center Boston Massachusetts 02215
Henry Ford Medical Center Detroit Michigan 48202
University of Minnesota Masonic Cancer Center Minneapolis Minnesota 55454
Mayo Clinic Rochester Minnesota 55905
Wake Forest University Winston-Salem North Carolina 27157
Medical University of South Carolina Charleston South Carolina 29425-6300
MD Anderson Cancer Center Houston Texas 77030
Providence Health Center Waco Texas 76712
Intermountain Healthcare Murray Utah 84157
Huntsman Cancer Institute Salt Lake City Utah 84112

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01566682, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 3, 2019 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01566682 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →