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NCT01566682 · ClinicalTrials.gov registry record
A Multi-Center Trial of the ProLung Test™
A clinical trial of Multiple Pulmonary Nodules and Solitary Pulmonary Nodule, sponsored by Fresh Medical Laboratories.
- Completed
- Registry status
- 420
- Enrollment target
- 15
- Study locations
NCT01566682 is a study of Multiple Pulmonary Nodules and Solitary Pulmonary Nodule that has completed, run by Fresh Medical Laboratories. The registered enrollment target is 420 participants, below the 916-participant average among 4 other Multiple Pulmonary Nodules trials with a reported enrollment target (54% lower). The trial reports 15 study locations across 10 states.
The verdict
NCT01566682, a study of Multiple Pulmonary Nodules and Solitary Pulmonary Nodule, has completed, sponsored by Fresh Medical Laboratories.
- COMPLETED
- Registry status
- 420 participants
- Enrollment target
- 15
- Study locations
Study 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 Studied
Study Locations (15)
California
- UCLA Medical Center - Los Angeles
- UCSD Medical Center - San Diego
- Stanford University Medical Center - Stanford
Minnesota
- University of Minnesota Masonic Cancer Center - Minneapolis
- Mayo Clinic - Rochester
Texas
- MD Anderson Cancer Center - Houston
- Providence Health Center - Waco
Utah
- Intermountain Healthcare - Murray
- Huntsman Cancer Institute - Salt Lake City
Illinois
- Loyola University Medical Center - Maywood
Maryland
- Greater Baltimore Medical Center - Towson
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Michigan
- Henry Ford Medical Center - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2012-10 |
| Est. Completion | 2019-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01566682
The ClinicalTrials.gov registry entry for NCT01566682 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 916-participant average among 4 other Multiple Pulmonary Nodules trials with a reported enrollment target (54% lower). The listed sponsor is Fresh Medical Laboratories, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Multiple Pulmonary Nodules appearing as the primary indexed condition, and to 0 interventions.
NCT01566682 reports 15 study locations spanning 10 distinct geographic areas - top geographies include California, Minnesota, Texas.
Frequently Asked Questions
What is clinical trial NCT01566682 about?
NCT01566682 is a clinical study titled "A Multi-Center Trial of the ProLung Test™". 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 resul...
What is the current status of trial NCT01566682?
This trial is currently completed. The enrollment target is 420 participants. The study started on 2012-10. Estimated completion is 2019-03.
What conditions does trial NCT01566682 study?
This clinical trial studies the following conditions: Multiple Pulmonary Nodules, Solitary Pulmonary Nodule.
Who is sponsoring clinical trial NCT01566682?
This trial is sponsored by Fresh Medical Laboratories, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01566682 being conducted?
This trial has 15 study locations across California, Illinois, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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