Early Diagnosis of Pulmonary Nodules

February 28, 2018 updated by: Integrated Diagnostics

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

684

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Institute Universitarie de Cardiologie et de Pneumologie
    • Ontario
      • Toronto, Ontario, Canada, M5G2C4
        • University Health Network - Toronto General Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital & Medical Center
      • Tucson, Arizona, United States, 85712
        • Pulmonary Associates of Southern Arizona
    • California
      • Los Angeles, California, United States, 90089
        • University of Southern California
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Georgia
      • Austell, Georgia, United States, 30106
        • Georgia Lung Associates
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Suburban Lung Associates
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Pulmonary Associates
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medical Center
      • Baltimore, Maryland, United States, 21237
        • Pulmonary & Crit Care Associates of Baltimore
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Health
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Royal Oak, Michigan, United States, 48703
        • Beaumont Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute - Allina Health
      • Rochester, Minnesota, United States, 55901
        • Mayo Clinic
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • St. Luke's Medical Center
    • New York
      • New York, New York, United States, 10016
        • New York University Clinical Cancer Center
    • North Carolina
      • Charleston, North Carolina, United States, 29403
        • Charleston Research Institute
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Healthcare System
      • Greensboro, North Carolina, United States, 27403
        • LeBaurer Healthcare
      • Winston-Salem, North Carolina, United States, 27103
        • Salem Chest Specialists
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97220
        • Oregon Clinic
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Philadelphia, Pennsylvania, United States, 10104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt-Ingram Cancer Center
    • Texas
      • Temple, Texas, United States, 76508
        • Scott & White Clinic
    • Virginia
      • Fairfax, Virginia, United States, 22042
        • Inova Healthcare
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer
Time Frame: 2 years post enrollment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integrated Diagnostics

Investigators

  • Study Director: Russell F. Hudnall, Integrated Diagnostics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

December 17, 2012

First Posted (Estimate)

December 19, 2012

Study Record Updates

Last Update Posted (Actual)

March 1, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANOPTIC (1001-12)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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