Study Results
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View full resultsBasic Information
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COMPLETED
420 participants
OBSERVATIONAL
2012-10-31
2019-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Indeterminate Pulmonary Lesions
Patients with Pulmonary Lesions as seen by CT
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Subject is male or female, age 18 or older.
2. Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions suspicious for lung cancer.
3. Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging.
4. Subject meets one or more of the following conditions:
* indicated for a tissue biopsy
* indicated for surgical resection of the lung
5. Subject must be able to receive a ProLung Test
* within 60 days of abnormal CT (Inclusion Criterion 2 \& 3)
* within 60 days prior to the tissue biopsy or surgical resection (Inclusion Criterion 4).
6. Subject is capable of understanding and agreeing to fulfill the requirements of this Protocol.
7. Subject has signed the IRB/IEC approved Informed Consent Form ("ICF").
Exclusion Criteria
1. Subject has an implanted electronic device in the chest.
2. Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis.
3. Subject with diagnosed malignancy other than lung cancer, non-melanoma skin cancer or any cancer in which the Principal Investigator does not suspect metastatic disease to the lung, who has 2 or more suspicious pulmonary nodules.
4. Subject has received an invasive medical or surgical procedure within the thoracic cavity within 30 days prior to the ProLung Test or within the previous 14 days for a bronchoscopic procedure.
5. Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement.
6. Subject will have undergone unusually strenuous exercise within 24 hours.
7. Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study.
18 Years
ALL
No
Sponsors
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Huntsman Cancer Institute
OTHER
University of California, Los Angeles
OTHER
Henry Ford Health System
OTHER
University of California, San Diego
OTHER
Intermountain Health Care, Inc.
OTHER
M.D. Anderson Cancer Center
OTHER
Greater Baltimore Medical Center
OTHER
Stanford University
OTHER
Loyola University
OTHER
Providence Health Center
UNKNOWN
Wake Forest
UNKNOWN
University of Minnesota Masonic Cancer Center
UNKNOWN
Beth Israel Deaconess Medical Center
OTHER
Medical University of South Carolina
OTHER
Fresh Medical Laboratories
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PL-208
Identifier Type: -
Identifier Source: org_study_id
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