Non-Invasive Biomarkers For Early Detection Of Lung Cancers

NCT01580332 | Completed

• 1 other identifier: ISRUSAL01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

biomarkers; lung cancer; solitary pulmonary nodules; SPN; breath analysis; VOC; volatile organic compounds; sputum; auto-antibodies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• newly diagnosed cancer, prior to treatment

You may not qualify if:

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

Sponsors & Collaborators

• Douglas W. Johnson MD, FACR: lead

Study Sites (1)

Baptist Cancer Institute, Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum; sputum

MeSH Terms

Conditions

Lung Neoplasms; Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Douglas W Johnson, MD

  Baptist Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: April 19, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 23, 2014

Record last verified: 2012-04

Locations

US (1)