Non-Invasive Biomarkers For Early Detection Of Lung Cancers
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | January 2012 |
| End Date: | April 2013 |
| Contact: | Douglas W Johnson, MD |
| Email: | djohnson@frogdocs.com |
| Phone: | 904-202-7020 |
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.
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.
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
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