Identification of a Plasma Proteomic Signature for Lung Cancer

This study is currently recruiting participants.
Verified May 2013 by Integrated Diagnostics
Sponsor:
Information provided by (Responsible Party):
Integrated Diagnostics
ClinicalTrials.gov Identifier:
NCT01752101
First received: November 30, 2012
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

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
Precancerous Conditions
Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of a Plasma Proteomic Signature for Lung Cancer

Resource links provided by NLM:


Further study details as provided by Integrated Diagnostics:

Primary Outcome Measures:
  • Incidence rate of Non-Small Cell Lung Cancer [ Time Frame: 24 months after enrollment ] [ Designated as safety issue: No ]
    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:
  • Panel of proteins [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752101

Contacts
Contact: Ken Fang, MD 206-576-6309 kfang@integrated-diagnostics.com

Locations
United States, California
Kaiser Permanente Northern California Recruiting
San Francisco, California, United States, 94115
Contact: Quyen Chau    415-833-3480      
Principal Investigator: Mark Lin, MD         
United States, Georgia
North East Alabama Regional Medical Center Recruiting
Anniston, Georgia, United States, 36207
Contact: Ruth Widdon, RN    256-235-5084    rwhiddon@rmccares.org   
Principal Investigator: George Crawford, MD         
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Troy Gogoll    443-849-3123    tgogoll@gbmc.org   
Principal Investigator: Neri Cohen, MD         
United States, Massachusetts
Lahey Hospital & Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Deborah Gannon    781-744-2734    deborah.j.gannon@lahey.com   
Principal Investigator: Christina Williamson, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Dusty Kah    313-916-1074    dkah1@hfhs.org   
Principal Investigator: Zane Hammoud, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Mary Karaus    507-538-8472    karats.mary@mayo.edu   
Principal Investigator: David Midthun, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Ruth Steele    513-584-2951    steelers@ucmail.uc.edu   
Principal Investigator: Sandra Starnes, MD         
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Duane Shaffer    570-271-6866    dlshaffer@geisinger.edu,   
Principal Investigator: Michael Ayers, MD         
United States, Texas
Cardiopulmonary Research Science and Technology Institute Recruiting
Dallas, Texas, United States, 75230
Contact: Melissa Johnson    972-566-2648    mjohnson@cristi.org   
Principal Investigator: Mitch Magee, MD         
United States, Utah
Intermountain Healthcare Recruiting
Murray, Utah, United States, 84107
Contact: Jean Flores    801-507-3609    jean.flores@imail.org   
Principal Investigator: Michael Collins, MD         
United States, Washington
Group Health Research Institute Recruiting
Seattle, Washington, United States, 98101
Contact: Kelly Hansen    206-287-2453    hansen.ke@ghc.org   
Principal Investigator: Jeff Sullivan, MD         
Sponsors and Collaborators
Integrated Diagnostics
Investigators
Study Director: Ken Fang, MD Integrated Diagnostics, Inc.
  More Information

No publications provided

Responsible Party: Integrated Diagnostics
ClinicalTrials.gov Identifier: NCT01752101     History of Changes
Other Study ID Numbers: 1013-12
Study First Received: November 30, 2012
Last Updated: May 24, 2013
Health Authority: United States: Quorum Review IRB

Keywords provided by Integrated Diagnostics:
Precancerous Conditions
Carcinoma

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Precancerous Conditions
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014