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Early Diagnosis of Pulmonary Nodules

Sponsor
Integrated Diagnostics (Industry)
Overall Status
Completed
CT.gov ID
NCT01752114
Collaborator
(none)
684
Enrollment
33
Locations
51
Duration (Months)
20.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    684 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12
    Study Start Date :
    Oct 1, 2012
    Actual Primary Completion Date :
    Dec 31, 2016
    Actual Study Completion Date :
    Dec 31, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Joseph's Hospital & Medical Center Phoenix Arizona United States 85013
    2 Pulmonary Associates of Southern Arizona Tucson Arizona United States 85712
    3 University of Southern California Los Angeles California United States 90089
    4 California Pacific Medical Center San Francisco California United States 94115
    5 Sarasota Memorial Hospital Sarasota Florida United States 34239
    6 Georgia Lung Associates Austell Georgia United States 30106
    7 Suburban Lung Associates Elk Grove Village Illinois United States 60007
    8 Kentuckiana Pulmonary Associates Louisville Kentucky United States 40202
    9 Pulmonary & Crit Care Associates of Baltimore Baltimore Maryland United States 21237
    10 Johns Hopkins Medical Center Baltimore Maryland United States 21287
    11 Baystate Health Springfield Massachusetts United States 01199
    12 Henry Ford Hospital Detroit Michigan United States 48202
    13 Beaumont Health System Royal Oak Michigan United States 48703
    14 Virginia Piper Cancer Institute - Allina Health Minneapolis Minnesota United States 55407
    15 Mayo Clinic Rochester Minnesota United States 55901
    16 St. Luke's Medical Center Chesterfield Missouri United States 63017
    17 New York University Clinical Cancer Center New York New York United States 10016
    18 Charleston Research Institute Charleston North Carolina United States 29403
    19 Carolinas HealthCare System Charlotte North Carolina United States 28203
    20 LeBaurer Healthcare Greensboro North Carolina United States 27403
    21 Salem Chest Specialists Winston-Salem North Carolina United States 27103
    22 Cleveland Clinic Cleveland Ohio United States 44195
    23 Oregon Clinic Portland Oregon United States 97220
    24 Geisinger Medical Center Danville Pennsylvania United States 17822
    25 University of Pennsylvania Philadelphia Pennsylvania United States 10104
    26 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    27 Medical University of South Carolina Charleston South Carolina United States 29425
    28 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37212
    29 Scott & White Clinic Temple Texas United States 76508
    30 Inova Healthcare Fairfax Virginia United States 22042
    31 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
    32 University Health Network - Toronto General Hospital Toronto Ontario Canada M5G2C4
    33 Institute Universitarie de Cardiologie et de Pneumologie Quebec Canada G1V 4G5

    Sponsors and Collaborators

    • Integrated Diagnostics

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Integrated Diagnostics
    ClinicalTrials.gov Identifier:
    NCT01752114
    Other Study ID Numbers:
    • PANOPTIC (1001-12)
    First Posted:
    Dec 19, 2012
    Last Update Posted:
    Mar 1, 2018
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Integrated Diagnostics
    Precancerous conditions
    Carcinoma
    Additional relevant MeSH terms:
    Multiple Pulmonary Nodules
    Precancerous Conditions

    Study Results

    No Results Posted as of Mar 1, 2018