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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01752114
Other study ID # PANOPTIC (1001-12)
Secondary ID
Status Completed
Phase N/A
First received November 30, 2012
Last updated February 28, 2018
Start date October 2012
Est. completion date December 31, 2016

Study information

Verified date August 2016
Source Integrated Diagnostics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Patients must present with previously non-diagnosed lung nodules as found on CT. There is no change to the typical standard of care that any of the investigating physicians and/or centers provide the patients enrolled in this study. The data from this study will not be used to diagnose cancer nor be used to influence treatment decisions for the study participants.


Recruitment information / eligibility

Status Completed
Enrollment 684
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- A prior CT scan is available that previously identifies the same lung nodule under consideration for study inclusion on the most current CT scan; AND the prior CT scan was performed more than 60 days before the current CT scan, irrespective of the candidate nodule's radiographic characterization such as size, density or appearance

- 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

Study Design


Locations

Country Name City State
Canada Institute Universitarie de Cardiologie et de Pneumologie Quebec
Canada University Health Network - Toronto General Hospital Toronto Ontario
United States Georgia Lung Associates Austell Georgia
United States Johns Hopkins Medical Center Baltimore Maryland
United States Pulmonary & Crit Care Associates of Baltimore Baltimore Maryland
United States Charleston Research Institute Charleston North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Carolinas HealthCare System Charlotte North Carolina
United States St. Luke's Medical Center Chesterfield Missouri
United States Cleveland Clinic Cleveland Ohio
United States Geisinger Medical Center Danville Pennsylvania
United States Henry Ford Hospital Detroit Michigan
United States Suburban Lung Associates Elk Grove Village Illinois
United States Inova Healthcare Fairfax Virginia
United States LeBaurer Healthcare Greensboro North Carolina
United States University of Southern California Los Angeles California
United States Kentuckiana Pulmonary Associates Louisville Kentucky
United States Virginia Piper Cancer Institute - Allina Health Minneapolis Minnesota
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States New York University Clinical Cancer Center New York New York
United States University of Pennsylvania Philadelphia Pennsylvania
United States St. Joseph's Hospital & Medical Center Phoenix Arizona
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States Oregon Clinic Portland Oregon
United States Mayo Clinic Rochester Minnesota
United States Beaumont Health System Royal Oak Michigan
United States California Pacific Medical Center San Francisco California
United States Sarasota Memorial Hospital Sarasota Florida
United States Fred Hutchinson Cancer Research Center Seattle Washington
United States Baystate Health Springfield Massachusetts
United States Scott & White Clinic Temple Texas
United States Pulmonary Associates of Southern Arizona Tucson Arizona
United States Salem Chest Specialists Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Integrated Diagnostics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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