NCT01085864

Biomarkers for Diagnosis of Lung Nodules

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 550 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Lung Abscess

Timeline

• Start date: 2010-03-17
• Primary completion: 2026-11-01
• Completion: 2027-10-01
• First posted: 2010-03-12
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States