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Completed

NCT Number: NCT01580332

Non-Invasive Biomarkers For Early Detection Of Lung Cancers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baptist Cancer Institute, Baptist Medical Center

Jacksonville, Florida, 32207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newly diagnosed cancer, prior to treatment

Exclusion criteria

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

Sponsors and collaborators

Lead sponsor

Douglas W. Johnson MD, FACR

Other

Registry information

Official study title

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

Acronym: ISRUSAL01

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 19, 2012
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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