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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01580332
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : July 23, 2014
Information provided by (Responsible Party):
Douglas W. Johnson MD, FACR, Baptist Cancer Institute

Brief Summary:

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.

Condition or disease
Lung Cancer

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Biospecimen Retention:   Samples With DNA
serum; sputum

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

Inclusion Criteria:

  • newly diagnosed cancer, prior to treatment

Exclusion Criteria:

  • prior treatment for this cancer
  • a history of any other cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01580332

United States, Florida
Baptist Cancer Institute, Baptist Medical Center
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Douglas W. Johnson MD, FACR
Principal Investigator: Douglas W Johnson, MD Baptist Cancer Institute

Responsible Party: Douglas W. Johnson MD, FACR, Principal Investigator, Baptist Cancer Institute Identifier: NCT01580332     History of Changes
Other Study ID Numbers: ISRUSAL01
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: April 2012

Keywords provided by Douglas W. Johnson MD, FACR, Baptist Cancer Institute:
lung cancer
solitary pulmonary nodules
breath analysis
volatile organic compounds

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases