Clinical trial NCT01752114: Early Diagnosis of Pulmonary Nodules
Official title: Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Precancerous Conditions
Carcinoma
Keywords: Precancerous conditions
Carcinoma
Lead sponsor: Integrated Diagnostics
Sponsor class: INDUSTRY
First posted: 2012-12-19
Enrollment: 684
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer
timeFrame: 2 years post enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center
state: Arizona
city: Tucson
country: United States
facility: Pulmonary Associates of Southern Arizona
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Austell
country: United States
facility: Georgia Lung Associates
state: Georgia
city: Elk Grove Village
country: United States
facility: Suburban Lung Associates
state: Illinois
city: Louisville
country: United States
facility: Kentuckiana Pulmonary Associates
state: Kentucky
city: Baltimore
country: United States
facility: Pulmonary & Crit Care Associates of Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Medical Center
state: Maryland
city: Springfield
country: United States
facility: Baystate Health
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Health System
state: Michigan
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute - Allina Health
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chesterfield
country: United States
facility: St. Luke's Medical Center
state: Missouri
city: New York
country: United States
facility: New York University Clinical Cancer Center
state: New York
city: Charleston
country: United States
facility: Charleston Research Institute
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas HealthCare System
state: North Carolina
city: Greensboro
country: United States
facility: LeBaurer Healthcare
state: North Carolina
city: Winston-Salem
country: United States
facility: Salem Chest Specialists
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Clinic
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Temple
country: United States
facility: Scott & White Clinic
state: Texas
city: Fairfax
country: United States
facility: Inova Healthcare
state: Virginia
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
city: Quebec
country: Canada
facility: Institute Universitarie de Cardiologie et de Pneumologie
Study officials:
affiliation: Integrated Diagnostics, Inc.
name: Russell F. Hudnall
role: STUDY_DIRECTOR
References:
citation: Silvestri 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.