Clinical Trial: Biomarkers for Diagnosis of Lung Nodules

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Biomarkers for Diagnosis of Lung Nodules

Brief Summary: A need exists for non-invasive testing to aid in clinical decision-making for Computerized Tomography (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.

Detailed Summary: 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.
Sponsor: University of Colorado, Denver

Current Primary Outcome: Evaluation of biomarkers in blood, sputum or urine. [ Time Frame: Baseline, 3-6 months, 12 months, 24 months, time of biopsy or surgery (if applicable), and 6 months post surgery (if applicable). ]

The primary hypothesis is that biomarkers detectable in blood, sputum, or urine will be useful for guiding clinical decisions in the setting of CT detected lung nodules.


Original Primary Outcome: 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 ]

Current Secondary Outcome: Evaluation of biomarkers after successful surgical treatment of malignant lung nodules. [ Time Frame: Within 3 years ]

The secondary hypothesis is that these biomarkers will decrease in concentration to the normal range after successful surgical treatment of malignant lung nodules.


Original Secondary Outcome: 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 ]

Information By: University of Colorado, Denver

Dates:
Date Received: March 10, 2010
Date Started: March 2010
Date Completion: April 2020
Last Updated: August 2, 2016
Last Verified: August 2016