Biomarkers for Diagnosis of Lung Nodules

NCT01085864 | Active Not Recruiting

• 1 other identifier: 09-1106.cc
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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.

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.

Outcome Measures

Primary Outcomes (1)

• Evaluation of biomarkers in blood, sputum or urine.

  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.

  Baseline, 3-6 months, 12 months, 24 months, time of biopsy or surgery (if applicable), and 6 months post surgery (if applicable).

Secondary Outcomes (1)

• Evaluation of biomarkers after successful surgical treatment of malignant lung nodules.

  Within 3 years

Study Arms (1)

Patients with lung nodules on CT scan.

Patients with lung nodules on CT scan.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients being evaluated by CT Scan with Lung Nocules

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimen, a sputum sample, a urine sample, and an exhaled breath sample.

MeSH Terms

Conditions

Lung Abscess

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Abscess; Suppuration; Lung Diseases; Respiratory Tract Diseases

Study Officials

• York E Miller, M.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 12, 2010
• Study Start: March 17, 2010
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)