Identification of a Plasma Proteomic Signature for Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Integrated Diagnostics
ClinicalTrials.gov Identifier:
NCT01752101
First received: November 30, 2012
Last updated: January 7, 2015
Last verified: January 2015
  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

Enrollment: 475
Study Start Date: October 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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   (Adult, Senior)
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
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: NCT01752101

Locations
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
Investigators
Study Director: Russell F. Hudnall Integrated Diagnostics, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: January 7, 2015
Health Authority: United States: Quorum Review IRB

Keywords provided by Integrated Diagnostics:
Precancerous Conditions
Carcinoma

Additional relevant MeSH terms:
Disease
Precancerous Conditions
Pathologic Processes
Neoplasms

ClinicalTrials.gov processed this record on August 25, 2016