Biomarkers for Diagnosis of Lung Nodules (Nodule)

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Abscess

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.

• Study Type: Observational
• Enrollment (Estimated): 550

Contacts and Locations

• Study Contact: Name: Brandi K Kubala; Phone Number: 303-724-1657; Email: brandi.kubala@cuanschutz.edu
• Study Contact Backup: Name: York E Miller, M.D.; Phone Number: 720-723-6429; Email: york.miller@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Brandi Kubala; Phone Number: 303-724-1657; Email: brandi.kubala@cuanschutz.edu
      • Principal Investigator: York E Miller, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients being evaluated by CT Scan with Lung Nocules

Description

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.

   -

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 -

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with lung nodules on CT scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of biomarkers after successful surgical treatment of malignant lung nodules.	The secondary hypothesis is that these biomarkers will decrease in concentration to the normal range after successful surgical treatment of malignant lung nodules.	Within 3 years

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: York E Miller, M.D., University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2010
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 10, 2010
• First Submitted That Met QC Criteria: March 11, 2010
• First Posted (Estimated): March 12, 2010

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• 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.
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Suppuration; Abscess; Lung Abscess
• Other Study ID Numbers: 09-1106.cc