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Biomarkers for Diagnosis of Lung Nodules (Nodule)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01085864
Recruitment Status : Active, not recruiting
First Posted : March 12, 2010
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 468 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Biomarkers for Diagnosis of Lung Nodules
Actual Study Start Date : January 8, 2010
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Group/Cohort
Patients with lung nodules on CT scan.
Patients with lung nodules on CT scan.



Primary Outcome Measures :
  1. 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). ]
    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.


Secondary Outcome Measures :
  1. Evaluation of biomarkers after successful surgical treatment of malignant lung nodules. [ Time Frame: Within 3 years ]
    The secondary hypothesis is that these biomarkers will decrease in concentration to the normal range after successful surgical treatment of malignant lung nodules.


Biospecimen Retention:   Samples With DNA
Blood specimen, a sputum sample, a urine sample, and an exhaled breath sample.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085864


Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: York E Miller, M.D. University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01085864    
Other Study ID Numbers: 09-1106.cc
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
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:
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Lung Abscess
Abscess
Suppuration
Infection
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections