Identification of a Plasma Proteomic Signature for Lung Cancer

January 7, 2015 updated by: Integrated Diagnostics
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

475

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

  • United States
    • California
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Northern California
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami - Sylvester Comprehensive Cancer Center
    • Georgia
      • Anniston, Georgia, United States, 36207
        • North East Alabama Regional Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital & Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Mayo Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
    • Texas
      • Dallas, Texas, United States, 75230
        • Cardiopulmonary Research Science and Technology Institute
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Healthcare
    • Washington
      • Seattle, Washington, United States, 98101
        • Group Health Research Institute

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

Probability Sample

Study Population

Patients undergoing procedure for histologic diagnosis of lung nodule(s)

Description

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

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 Non-Small Cell Lung Cancer
Time Frame: 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.
24 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Panel of proteins
Time Frame: 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.
At the end of the study

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 1, 2014

Study Completion (Actual)

December 1, 2014

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 (Estimate)

January 9, 2015

Last Update Submitted That Met QC Criteria

January 7, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1013-12

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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