Non-Invasive Biomarkers For Early Detection Of Lung Cancers (ISRUSAL01)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Douglas W. Johnson MD, FACR, Baptist Cancer Institute
ClinicalTrials.gov Identifier:
NCT01580332
First received: April 17, 2012
Last updated: July 22, 2014
Last verified: April 2012

April 17, 2012
July 22, 2014
January 2012
June 2014   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01580332 on ClinicalTrials.gov Archive Site
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Non-Invasive Biomarkers For Early Detection Of Lung Cancers
NON-INVASIVE BIOMARKERS FOR EARLY DETECTION OF LUNG CANCERS: ELEMENT 1: NON-RANDOMIZED PHASE II EVALUATION AND VALIDATION IN NEWLY DIAGNOSED LUNG CANCER PATIENTS

Recent studies have shown that low-dose chest CT scans can detect lung cancers in high-risk populations (age >50yo, >30 pack-years of tobacco use), and can lower cancer mortality. Unfortunately, the vast majority of "positive" findings on these CT scans are benign (>95%). Currently, an inordinate amount of expensive follow-up testing is required for these patients to try to prove who among them truly has a cancer.

Several new emerging non-invasive and potentially cheaper tests are now being investigated to help differentiate patients with cancers versus just benign lung nodules. These new tests include a new type of sputum analysis, a breath analysis, a blood test measuring certain tumor markers, a blood test looking for auto-antibodies, and a standard PET/CT scan. Each of these tests have different sensitivity and specificity rates when looking for lung cancer, and it is unclear which test is best.

This study will employ a panel of all 5 of these non-invasive tests on an initial cohort of 50 patients with recently diagnosed lung cancer to try to measure the sensitivity of the tests. A follow-on study will then perform the same panel of tests on 300 lung nodule patients to see which test, or combination of tests, gives the best overall accuracy in terms of predicting who really has lung cancer. It is hoped that the use of such a panel could lead to dramatically decreased need for expensive and morbid invasive testing for this population.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

serum; sputum

Non-Probability Sample

any patient with newly diagnosed lung cancer (any histology, any stage) who has not yet begun definitive treatment, and who has no prior history of cancer of any type

Lung Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • newly diagnosed cancer, prior to treatment

Exclusion Criteria:

  • prior treatment for this cancer
  • a history of any other cancer
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01580332
ISRUSAL01
No
Douglas W. Johnson MD, FACR, Baptist Cancer Institute
Douglas W. Johnson MD, FACR
Not Provided
Principal Investigator: Douglas W Johnson, MD Baptist Cancer Institute
Baptist Cancer Institute
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP