Early Diagnosis of Pulmonary Nodules

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Integrated Diagnostics
Sponsor:
Information provided by (Responsible Party):
Integrated Diagnostics
ClinicalTrials.gov Identifier:
NCT01752114
First received: November 30, 2012
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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
Precancerous Conditions
Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Diagnosis of Pulmonary Nodules Using A Plasma Proteomic Classifier, Protocol Number 1001-12

Resource links provided by NLM:


Further study details as provided by Integrated Diagnostics:

Primary Outcome Measures:
  • Incidence rate of adult patients diagnosed with Non-Small Cell Lung Cancer [ Time Frame: 2 years post enrollment ] [ Designated as safety issue: No ]
    Incidence rate of Non-Small Cell Lung Cancer as determined by histologic or cytologic diagnosis and/or radiographically stability at 2 years post enrollment.


Biospecimen Retention:   Samples Without DNA

Blood samples


Estimated Enrollment: 1600
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

Subject undergoing evaluation for a lung nodule by a pulmonologist in a pulmonary or chest clinic, and/or by a thoracic surgeon at the time of enrollment

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752114

  Hide Study Locations
Locations
United States, Arizona
St. Joseph's Hospital & Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Veta Markland-Gentles, RN, CCRN    602-406-5853    veta.marklandgentles@dignityhealth.org   
Principal Investigator: Elbert Kuo, MD         
Pulmonary Associates of Southern Arizona Recruiting
Tucson, Arizona, United States, 85712
Contact: Michelle Henderson    520-318-1124 ext 112    Michelle@pasatucson.com   
Principal Investigator: Rob Aaronson, MD         
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90089
Contact: Lynn Fukushima    323-442-5869    lynn.fukushima@med.usc.edu   
Principal Investigator: Dr. Alex Balekian         
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Benjamin Luna    415-600-3786    LunaBG@cpmcri.org   
Principal Investigator: George Horng, MD         
United States, Florida
Sarasota Memorial Hospital Recruiting
Sarasota, Florida, United States, 34239
Contact: Mary Bradley, RN    941-917-6164    mary-bradley@smh.com   
Principal Investigator: Kirk Voelker, MD         
United States, Georgia
Georgia Lung Associates Recruiting
Austell, Georgia, United States, 30106
Contact: Liz Wilkins    770-745-1404 ext 6    lwilkins_gcr@yahoo.com   
Principal Investigator: Amy Hajari Case, MD         
United States, Illinois
Suburban Lung Associates Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Mary Joseph, PhD    847-981-3660    mary.joseph@sublung.com   
Principal Investigator: Neeraj Desai, MD         
United States, Kentucky
Kentuckiana Pulmonary Associates Recruiting
Louisville, Kentucky, United States, 40202
Contact: Kim Hobbs, APRN    502-419-3410    mcco3526@bellsouth.net   
Principal Investigator: Wes McConnell, MD         
United States, Maryland
Pulmonary & Crit Care Associates of Baltimore Recruiting
Baltimore, Maryland, United States, 21237
Contact: Christopher Fletcher    410-494-7978    cfletcher@pccabpa.com   
Principal Investigator: William Krimsky, MD         
Johns Hopkins Medical Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Karen Oakjones-Burgess    410-955-5288    kfriel2@jhmi.edu   
Principal Investigator: Lonny Yarmus, MD         
United States, Massachusetts
Baystate Health Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Lesley DeSouza    413-794-5584    Lesley.desouza@baystatehealth.org   
Principal Investigator: John Landis, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Dusty Kah    313-916-1074    dkah1@hfhs.org   
Principal Investigator: Dr. Zane Hammoud         
Beaumont Health System Recruiting
Royal Oak, Michigan, United States, 48703
Contact: Gina Casanova    248-551-2041    Gina.casanova@beaumont.edu   
Principal Investigator: K.P. Ravikrishnan, MD         
United States, Minnesota
Virginia Piper Cancer Institute - Allina Health Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Lisa Albers, RN    612-863-9466    lisa.albers@allina.com   
Principal Investigator: Joseph Leach, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Mary Karaus    507-538-8472    midthun.david@mayo.edu   
Principal Investigator: David Midthun, MD         
United States, Missouri
St. Luke's Medical Center Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Jennifer Crocker       Jennifer.Crocker@stlukes-stl.com   
Contact: Tammy Setchfield       Tammy.Setchfield@stlukes-stl.com   
Principal Investigator: Neil Ettinger, MD         
United States, New York
New York University Clinical Cancer Center Recruiting
New York, New York, United States, 10016
Contact: Audrey Sorensen    212-263-2562      
Principal Investigator: Harvey Pass         
Sub-Investigator: William Rom, MD         
United States, North Carolina
Charleston Research Institute Recruiting
Charleston, North Carolina, United States, 29403
Contact: Kalon Eways    843-792-6696    eways@musc.edu   
Principal Investigator: Nicole Tanner, MD         
Carolinas HealthCare System Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Shamedria Simmons, CCRP    704-335-9349    Shamedria.Simmons@carolinashealthcare.org   
Principal Investigator: Kathryn Mileham, MD         
LeBaurer Healthcare Recruiting
Greensboro, North Carolina, United States, 27403
Contact: Arshena Overton    336-832-2778    Arshena.Overton@conehealth.com   
Principal Investigator: Murali Ramaswamy, MD         
Salem Chest Specialists Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Karen McCutcheon    336-659-8414    kmccutcheon@southeasternresearchcenter.com   
Principal Investigator: Barry Sigal, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Mary Beukemann    216-445-8951    beukemm@ccf.org   
Principal Investigator: Peter Mazzone, MD         
United States, Oregon
Oregon Clinic Recruiting
Portland, Oregon, United States, 97220
Contact: Arlena Loos, RN    503-963-3183    aloos@orclinic.com   
Principal Investigator: Asha Chestnutt, MD         
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Amy Brigham    570-214-9544    arbrigham@geisinger.edu   
Principal Investigator: Michael Ayers, MD         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 10104
Contact: Kristina Maletteri       krisma@mail.med.upenn.edu   
Principal Investigator: Anil Vachani, MD         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Irina Marskaya, MD    412-359-4591    IBARSKAY@wpahs.org   
Principal Investigator: Marvin Balaan, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Mary Brooks    843-792-4557    broomary@musc.edu   
Principal Investigator: Gerard Silvestri, MD         
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Anel Muterspaugh,    615-936-4244    anel.w.muterspaugh@vanderbilt.edu   
Principal Investigator: Pierre Massion, MD         
United States, Texas
Scott & White Clinic Recruiting
Temple, Texas, United States, 76508
Contact: Craig Cernosek, DC    524-724-5537    ccernosek@sw.org   
Principal Investigator: Juan Sanchez, MD         
United States, Virginia
Inova Healthcare Recruiting
Fairfax, Virginia, United States, 22042
Contact: Christina Krawiecki    703-776-4021    Christina.Krawiecki@inova.org   
Principal Investigator: James Lamberti, MD         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Keira Oh    206-667-5120      
Principal Investigator: David K Madtes, MD         
Canada
Institute Universitarie de Cardiologie et de Pneumologie Recruiting
Quebec, Canada, G1V 4G5
Contact: Brigitte Fortin    418-656-8711 ext 2639    Brigitte.Fortin@criucpq.ulaval.ca   
Principal Investigator: Francis Laberge, MD         
Sponsors and Collaborators
Integrated Diagnostics
Investigators
Study Director: Kenneth Fang, MD Integrated Diagnostics, Inc.
  More Information

No publications provided

Responsible Party: Integrated Diagnostics
ClinicalTrials.gov Identifier: NCT01752114     History of Changes
Other Study ID Numbers: 1001-12
Study First Received: November 30, 2012
Last Updated: October 31, 2013
Health Authority: United States: Quorum Review IRB

Keywords provided by Integrated Diagnostics:
Precancerous conditions
Carcinoma

Additional relevant MeSH terms:
Carcinoma
Precancerous Conditions
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 20, 2014