Early Diagnosis of Pulmonary Nodules

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Integrated Diagnostics
ClinicalTrials.gov Identifier:
NCT01752114
First received: November 30, 2012
Last updated: January 7, 2015
Last verified: January 2015
  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

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 With DNA

Blood samples


Enrollment: 682
Study Start Date: October 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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
Phoenix, Arizona, United States, 85013
Pulmonary Associates of Southern Arizona
Tucson, Arizona, United States, 85712
United States, California
University of Southern California
Los Angeles, California, United States, 90089
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, Florida
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
United States, Georgia
Georgia Lung Associates
Austell, Georgia, United States, 30106
United States, Illinois
Suburban Lung Associates
Elk Grove Village, Illinois, United States, 60007
United States, Kentucky
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States, 40202
United States, Maryland
Pulmonary & Crit Care Associates of Baltimore
Baltimore, Maryland, United States, 21237
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Baystate Health
Springfield, Massachusetts, United States, 01199
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Beaumont Health System
Royal Oak, Michigan, United States, 48703
United States, Minnesota
Virginia Piper Cancer Institute - Allina Health
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55901
United States, Missouri
St. Luke's Medical Center
Chesterfield, Missouri, United States, 63017
United States, New York
New York University Clinical Cancer Center
New York, New York, United States, 10016
United States, North Carolina
Charleston Research Institute
Charleston, North Carolina, United States, 29403
Carolinas HealthCare System
Charlotte, North Carolina, United States, 28203
LeBaurer Healthcare
Greensboro, North Carolina, United States, 27403
Salem Chest Specialists
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Clinic
Portland, Oregon, United States, 97220
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 10104
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37212
United States, Texas
Scott & White Clinic
Temple, Texas, United States, 76508
United States, Virginia
Inova Healthcare
Fairfax, Virginia, United States, 22042
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Canada, Ontario
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G2C4
Canada
Institute Universitarie de Cardiologie et de Pneumologie
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Integrated Diagnostics
Investigators
Study Director: Russell F. Hudnall 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: January 7, 2015
Health Authority: United States: Quorum Review IRB

Keywords provided by Integrated Diagnostics:
Precancerous conditions
Carcinoma

Additional relevant MeSH terms:
Multiple Pulmonary Nodules
Precancerous Conditions
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on April 26, 2015