Biomarkers for Diagnosis of Lung Nodules
A need exists for non-invasive testing to aid in clinical decision-making for CT scan detected lung nodules of indeterminate etiology. The investigators hypothesize that biomarkers detectable in blood, sputum or urine may be useful for guiding clinical decisions in the setting of CT detected lung nodules to determine which nodules are malignant and which are benign. The investigators also hypothesize that these biomarkers will decrease in concentration to the normal range after successful surgical treatment of malignant lung nodules.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Biomarkers for Diagnosis of Lung Nodules|
- The primary hypothesis is that biomarkers detectable in blood , sputum or urine will be useful for guiding clinical decision in the setting of CT detected lung nodules. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- The secondary hypothesis is that these biomarkers will decrease in concentration to the normal range after successful surgical treatment of malignant lung nodules. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood specimen, a sputum sample, a urine sample, and an exhaled breath sample.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||April 2020|
|Estimated Primary Completion Date:||April 2018 (Final data collection date for primary outcome measure)|
|Patients with lung nodules on CT scan.|
The Biomarkers for Diagnosis of Lung Nodules Study is a prospective study of a cohort of 500 individuals with lung nodules of indeterminate etiology that are identified by CT scans. Either biopsy or repeat CT scans must be clinically indicated to determine the etiology of the nodule. Patients will be asked to allow investigators access to CT scan images and spirometry data, and provide blood, sputum, urine, and exhaled breath samples over the course of the study. Patients will also be asked to allow investigators to access pathology records if a biopsy or surgical excision of the nodule is clinically indicated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085864
|Contact: Mary K Jacksonfirstname.lastname@example.org|
|Contact: York E Miller, M.D.||email@example.com|
|United States, Colorado|
|University of Colorado Anschutz Medical Campus||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Mary K Jackson 303-724-1650 firstname.lastname@example.org|
|Principal Investigator: York E Miller, M.D.|