Biomarkers for Diagnosis of Lung Nodules (Nodule)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 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: August 2, 2016
Last verified: August 2016

March 10, 2010
August 2, 2016
March 2010
April 2018   (final data collection date for primary outcome measure)
Evaluation of biomarkers in blood, sputum or urine. [ Time Frame: Baseline, 3-6 months, 12 months, 24 months, time of biopsy or surgery (if applicable), and 6 months post surgery (if applicable). ] [ Designated as safety issue: No ]
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.
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 ]
Complete list of historical versions of study NCT01085864 on ClinicalTrials.gov Archive Site
Evaluation of biomarkers after successful surgical treatment of malignant lung nodules. [ Time Frame: Within 3 years ] [ Designated as safety issue: No ]
The secondary hypothesis is that these biomarkers will decrease in concentration to the normal range 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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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 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.
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
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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
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Patients with lung nodules on CT scan.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
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 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 dimention.
  2. Lung nodules that have solid calification.
  3. Lung nodules or masses with CT evidence of partial or complete obstruciton of a lobar bronshus, mainstem bronchus or the trachea.
  4. No prior cancer with the exception of non-melanoma skin cancer.
  5. Life expectany of < 6 months
  6. Any indifidual who does not give oral and written consent for participation -
Both
18 Years to 85 Years   (Adult, Senior)
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
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: York E Miller, M.D. University of Colorado, Denver
University of Colorado, Denver
August 2016

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