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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
  Purpose

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.


Condition
Lung Abscess

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Biomarkers for Diagnosis of Lung Nodules

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 600
Study Start Date: March 2010
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with lung nodules on CT scan.

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients being evaluated by CT Scan with Lung Nocules

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 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.

    -

    Exclusion Criteria:

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085864

Contacts
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

Locations
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Mary K Jackson    303-724-1650    mary.k.jackson@ucdenver.edu   
Principal Investigator: York E Miller, M.D.         
Sponsors and Collaborators
University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01085864     History of Changes
Other Study ID Numbers: 09-1106
Study First Received: March 10, 2010
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
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:
Lung Abscess
Abscess
Infection
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Suppuration

ClinicalTrials.gov processed this record on November 25, 2014