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NON-INVASIVE BIOMARKERS FOR EARLY DETECTION OF LUNG CANCERS: ELEMENT 1: NON-RANDOMIZED PHASE II EVALUATION AND VALIDATION IN NEWLY DIAGNOSED LUNG CANCER PATIENTS


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

NON-INVASIVE BIOMARKERS FOR EARLY DETECTION OF LUNG CANCERS: ELEMENT 1: NON-RANDOMIZED PHASE II EVALUATION AND VALIDATION IN NEWLY DIAGNOSED LUNG CANCER PATIENTS


The study revolves around specifying the exact signatures and accuracy associated with
discriminating between benign and malignant SPNs for each of the biomarkers in the specific
high risk cohort under the NLST screening protocol. To help identify and quantify these
signatures, we will evaluate specifically the volatile signature in the exhaled breath, the
accuracy of LuCED sputum detection, the profile of tumor markers and the specifications of
auto-antibodies through immunoassays and Orbitrap technology, and the PET/CT in patients
already diagnosed with lung cancer.


Inclusion Criteria:



- newly diagnosed cancer, prior to treatment

Exclusion Criteria:

- prior treatment for this cancer

- a history of any other cancer

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Douglas W Johnson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baptist Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

ISRUSAL01

NCT ID:

NCT01580332

Start Date:

January 2012

Completion Date:

April 2013

Related Keywords:

  • Lung Cancer
  • biomarkers
  • lung cancer
  • solitary pulmonary nodules
  • SPN
  • breath analysis
  • VOC
  • volatile organic compounds
  • sputum
  • auto-antibodies
  • Lung Neoplasms

Name

Location

Baptist Cancer Institute, Baptist Medical Center Jacksonville, Florida  32207