Early Diagnosis of Pulmonary Nodules

NCT ID: NCT01752114

Last Updated: 2018-03-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 684 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-12-31

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.

Conditions

Precancerous Conditions; Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Integrated Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russell F. Hudnall

Role: STUDY_DIRECTOR

Integrated Diagnostics, Inc.

Locations

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, United States

Pulmonary Associates of Southern Arizona

Tucson, Arizona, United States

University of Southern California

Los Angeles, California, United States

California Pacific Medical Center

San Francisco, California, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Georgia Lung Associates

Austell, Georgia, United States

Suburban Lung Associates

Elk Grove Village, Illinois, United States

Kentuckiana Pulmonary Associates

Louisville, Kentucky, United States

Pulmonary & Crit Care Associates of Baltimore

Baltimore, Maryland, United States

Johns Hopkins Medical Center

Baltimore, Maryland, United States

Baystate Health

Springfield, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Beaumont Health System

Royal Oak, Michigan, United States

Virginia Piper Cancer Institute - Allina Health

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

St. Luke's Medical Center

Chesterfield, Missouri, United States

New York University Clinical Cancer Center

New York, New York, United States

Charleston Research Institute

Charleston, North Carolina, United States

Carolinas HealthCare System

Charlotte, North Carolina, United States

LeBaurer Healthcare

Greensboro, North Carolina, United States

Salem Chest Specialists

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Oregon Clinic

Portland, Oregon, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Scott & White Clinic

Temple, Texas, United States

Inova Healthcare

Fairfax, Virginia, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Institute Universitarie de Cardiologie et de Pneumologie

Québec, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 40296864 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29496499 (View on PubMed)

Other Identifiers

PANOPTIC (1001-12)

Identifier Type: -

Identifier Source: org_study_id