Early Diagnosis of Pulmonary Nodules

Carcinoma Clinical Trial

Official title:

Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752114
• Other study ID #: PANOPTIC (1001-12)
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma
• Multiple Pulmonary Nodules
• Precancerous Conditions

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