Biomarkers for Diagnosis of Lung Nodules

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01085864
First received: March 10, 2010
Last updated: May 5, 2014
Last verified: May 2014

March 10, 2010
May 5, 2014
March 2010
April 2018   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01085864 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Biomarkers for Diagnosis of Lung Nodules
Biomarkers for Diagnosis of Lung Nodules

A need exists for non-invasive testing to aid in clinical decision-making for 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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Probability Sample

Patients being evaluated by CT Scan with Lung Nocules

Lung Abscess
Not Provided
Patients with lung nodules on CT scan.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
April 2020
April 2018   (final data collection date for primary outcome measure)

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 5 mm and 50 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:

    -

Both
18 Years to 85 Years
No
Contact: Mary K Jackson 303-724-1650 mary.k.jackson@ucdenver.edu
Contact: York E Miller, M.D. 303-393-2869 york.miller@ucdenver.edu
United States
 
NCT01085864
09-1106
No
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Not Provided
University of Colorado, Denver
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP