Clinical trial NCT01085864: Biomarkers for Diagnosis of Lung Nodules
Official title: Biomarkers for Diagnosis of Lung Nodules
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Abscess
Keywords: Lung Nodules
A need exists for non-invasive testing to aid in clinical decision-making for CT scan detected lung nodules of indeterminate etiology.
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2010-03-12
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients being evaluated by CT Scan with Lung Nocules

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 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.

Eligibility criteria: Inclusion Criteria:

1. Adult 18-85 years of age
2. Patients referred to pulmonologists, oncologists, or thoracic surgeons for the evaluation of peripheral lung nodules found on CT scan.
3. Repeat CT scans, biopsy or surgical excision are clinically indicated to determine the etiology of the nodule.
4. One or more lung nodules must be between 8 mm and 30 mm in the greatest diameter.
5. Patients must be fully informed of the investigational nature of the procedure and sign an informed consent.

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Exclusion Criteria:

1. Lung nodules or masses greater than 30 mm in the greatest dimension.
2. Lung nodules that have solid calcification.
3. Lung nodules or masses with CT evidence of partial or complete obstruction of a lobar bronchus, main stem bronchus or the trachea.
4. No prior cancer with the exception of non-melanoma skin cancer.
5. Life expectancy of \< 6 months
6. Any individual who does not give oral and written consent for participation -

Primary outcomes:
measure: Evaluation of biomarkers in blood, sputum or urine.
timeFrame: Baseline, 3-6 months, 12 months, 24 months, time of biopsy or surgery (if applicable), and 6 months post surgery (if applicable).
Secondary outcomes:
measure: Evaluation of biomarkers after successful surgical treatment of malignant lung nodules.
timeFrame: Within 3 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: York E Miller, M.D.
role: PRINCIPAL_INVESTIGATOR
References: