Early Diagnosis of Pulmonary Nodules
1 other identifier
observational
684
2 countries
33
Brief Summary
This study is intended to determine the positive predictive value (PPV) and negative predictive value (NPV) of the multiprotein classifier based on the observed study prevalence of Non-Small Cell Lung Cancer (NSCLC) in the study participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2012
Longer than P75 for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 30, 2012
CompletedFirst Posted
Study publicly available on registry
December 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2016
CompletedMarch 1, 2018
August 1, 2016
4.3 years
November 30, 2012
February 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer
Incidence rate of Non-Small Cell Lung Cancer as determined by histologic or cytologic diagnosis and/or radiographically stability at 2 years post enrollment.
2 years post enrollment
Eligibility Criteria
Subject undergoing evaluation for a lung nodule by a pulmonologist in a pulmonary or chest clinic, and/or by a thoracic surgeon at the time of enrollment
You may qualify if:
- Age ≥ 40 years
- Smoking history: Never, Former, Current
- Subject undergoing diagnostic evaluation for a lung nodule
- Subject undergoing evaluation for a lung nodule by a pulmonologist, and/or by a thoracic surgeon
- Baseline CT scan identifying lung nodule performed within 60 days of subject enrollment
- Nodule(s) identified by CT scan previously not followed
- Subject willing to provide informed consent for the collection of blood specimens
You may not qualify if:
- Nodule work-up at the time of enrollment eligibility indicates any prior attempted or completed diagnostic biopsy procedure, such as transthoracic needle aspiration, bronchoscopic biopsy or surgery
- Current diagnosis of any cancer
- Prior diagnosis of any cancer within 2 years of lung nodule detection, except for non-melanoma skin cancer
- Administration of blood products, e.g. packed red blood cells, fresh frozen plasma, or platelets, within 30 days of subject enrollment
- History of human immunodeficiency virus (HIV) or Hepatitis C
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013, United States
Pulmonary Associates of Southern Arizona
Tucson, Arizona, 85712, United States
University of Southern California
Los Angeles, California, 90089, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Georgia Lung Associates
Austell, Georgia, 30106, United States
Suburban Lung Associates
Elk Grove Village, Illinois, 60007, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202, United States
Pulmonary & Crit Care Associates of Baltimore
Baltimore, Maryland, 21237, United States
Johns Hopkins Medical Center
Baltimore, Maryland, 21287, United States
Baystate Health
Springfield, Massachusetts, 01199, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Beaumont Health System
Royal Oak, Michigan, 48703, United States
Virginia Piper Cancer Institute - Allina Health
Minneapolis, Minnesota, 55407, United States
Mayo Clinic
Rochester, Minnesota, 55901, United States
St. Luke's Medical Center
Chesterfield, Missouri, 63017, United States
New York University Clinical Cancer Center
New York, New York, 10016, United States
Charleston Research Institute
Charleston, North Carolina, 29403, United States
Carolinas HealthCare System
Charlotte, North Carolina, 28203, United States
LeBaurer Healthcare
Greensboro, North Carolina, 27403, United States
Salem Chest Specialists
Winston-Salem, North Carolina, 27103, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Clinic
Portland, Oregon, 97220, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 10104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212, United States
Scott & White Clinic
Temple, Texas, 76508, United States
Inova Healthcare
Fairfax, Virginia, 22042, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G2C4, Canada
Institute Universitarie de Cardiologie et de Pneumologie
Québec, Quebec, G1V 4G5, Canada
Related Publications (2)
Long KJ, Silvestri GA, Kammer MN, Gibbs S, Wu W, Johal M, Pipavath S, Pitcher T, Jett J, Nair VS. Validation of a High-Specificity Blood Autoantibody Test to Detect Lung Cancer in Pulmonary Nodules. CHEST Pulm. 2025 Mar;3(1):100130. doi: 10.1016/j.chpulm.2024.100130. Epub 2024 Dec 25.
PMID: 40296864DERIVEDSilvestri GA, Tanner NT, Kearney P, Vachani A, Massion PP, Porter A, Springmeyer SC, Fang KC, Midthun D, Mazzone PJ; PANOPTIC Trial Team. Assessment of Plasma Proteomics Biomarker's Ability to Distinguish Benign From Malignant Lung Nodules: Results of the PANOPTIC (Pulmonary Nodule Plasma Proteomic Classifier) Trial. Chest. 2018 Sep;154(3):491-500. doi: 10.1016/j.chest.2018.02.012. Epub 2018 Mar 1.
PMID: 29496499DERIVED
Biospecimen
Blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Russell F. Hudnall
Integrated Diagnostics, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2012
First Posted
December 19, 2012
Study Start
October 1, 2012
Primary Completion
December 31, 2016
Study Completion
December 31, 2016
Last Updated
March 1, 2018
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share