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
  Purpose

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
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Baptist Cancer Institute:

Biospecimen Retention:   Samples With DNA

serum; sputum


Estimated Enrollment: 50
Study Start Date: January 2012
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

  • newly diagnosed cancer, prior to treatment

Exclusion Criteria:

  • prior treatment for this cancer
  • a history of any other cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580332

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

No publications provided

Responsible Party: Douglas W. Johnson MD, FACR, Principal Investigator, Baptist Cancer Institute
ClinicalTrials.gov Identifier: NCT01580332     History of Changes
Other Study ID Numbers: ISRUSAL01
Study First Received: April 17, 2012
Last Updated: July 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Baptist Cancer Institute:
biomarkers
lung cancer
solitary pulmonary nodules
SPN
breath analysis
VOC
volatile organic compounds
sputum
auto-antibodies

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

ClinicalTrials.gov processed this record on August 01, 2014