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Identification of a Plasma Proteomic Signature for Lung Cancer

Sponsor
Integrated Diagnostics (Industry)
Overall Status
Completed
CT.gov ID
NCT01752101
Collaborator
(none)
475
Enrollment
12
Locations
26
Duration (Months)
39.6
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to identify a panel of plasma and/or serum proteins that differentiates the absence or presence of lung malignancy in samples obtained from subjects enrolled in this IRB/EC approved study with pulmonary nodules.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Blood samples are obtained from those patients undergoing procedures to determine if a lung nodule is benign or cancerous. The data from the study will not be used to guide or influence the treatment of the patients enrolled in this study. There is no change from the normal standard of care that patients receive.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    475 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Identification of a Plasma Proteomic Signature for Lung Cancer
    Study Start Date :
    Oct 1, 2012
    Actual Primary Completion Date :
    Dec 1, 2014
    Actual Study Completion Date :
    Dec 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Incidence rate of Non-Small Cell Lung Cancer [24 months after enrollment]

      The incidence rate of non-small cell lung cancer in the study population will be correlated to the predictive value of the Sponsor's blood test.

    Secondary Outcome Measures

    1. Panel of proteins [At the end of the study]

      The positive and negative predictive value of the test to differentiate between malignancy and inflammatory diseases such as granulomatous disorders.

    Eligibility Criteria

    Criteria

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

    • age ≥ 40

    • any smoking status, e.g. current, former, or never

    • co-morbid conditions, e.g. COPD

    • Nodule size ≥ 4 mm and ≤ 30 mm (up to Stage 2B eligible), any spiculation or ground glass opacity

    • Pathology: malignant - adenocarcinoma, squamous, or large cell

    • Pathology: benign - inflammatory (e.g. granulomatous, infectious) or non-inflammatory (e.g. hamartoma)

    • Clinical stage, Primary tumor: ≤T2 (e.g. 1A, 1B, 2A and 2B)

    • Clinical stage, Regional lymph nodes: N0 or N1 only

    • Clinical stage, Distant metastasis: M0 only

    Exclusion Criteria:

    • prior malignancy within 5 years of lung nodule diagnosis

    • No nodule size available

    • No pathology data available for those with

    • Current diagnosis of non-small cell lung cancer

    • Clinical stage: Primary tumor ≥T3; Regional lymph nodes: ≥N2; 4 Distant metastasis: ≥M1

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaiser Permanente Northern California San Francisco California United States 94115
    2 University of Miami - Sylvester Comprehensive Cancer Center Miami Florida United States 33136
    3 North East Alabama Regional Medical Center Anniston Georgia United States 36207
    4 Greater Baltimore Medical Center Baltimore Maryland United States 21204
    5 Lahey Hospital & Medical Center Burlington Massachusetts United States 01805
    6 Henry Ford Hospital Detroit Michigan United States 48202
    7 Mayo Clinic Rochester Minnesota United States 55901
    8 University of Cincinnati Cincinnati Ohio United States 45267
    9 Geisinger Medical Center Danville Pennsylvania United States 17822
    10 Cardiopulmonary Research Science and Technology Institute Dallas Texas United States 75230
    11 Intermountain Healthcare Murray Utah United States 84107
    12 Group Health Research Institute Seattle Washington United States 98101

    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:
    NCT01752101
    Other Study ID Numbers:
    • 1013-12
    First Posted:
    Dec 19, 2012
    Last Update Posted:
    Jan 9, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Integrated Diagnostics
    Precancerous Conditions
    Carcinoma
    Additional relevant MeSH terms:
    Precancerous Conditions

    Study Results

    No Results Posted as of Jan 9, 2015