Identification of a Plasma Proteomic Signature for Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01752101
Recruitment Status : Completed
First Posted : December 19, 2012
Last Update Posted : January 9, 2015
Information provided by (Responsible Party):
Integrated Diagnostics

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
Precancerous Conditions Carcinoma

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples Without DNA
Blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing procedure for histologic diagnosis of lung nodule(s)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01752101

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Integrated Diagnostics Identifier: NCT01752101     History of Changes
Other Study ID Numbers: 1013-12
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015

Keywords provided by Integrated Diagnostics:
Precancerous Conditions

Additional relevant MeSH terms:
Precancerous Conditions