The Use of High Resolution Chest Computed Tomography in Alpha-1 Antitrypsin Deficiency (QUANTUM-1)
Individuals with a deficiency of alpha-1 antitrypsin (AAT) often develop emphysema. Traditional lung function tests may not be the most accurate way to measure the progression of emphysema. This study will compare high resolution computed tomography (CT) scans to spirometry to measure the progression of emphysema.
Alpha-1 Antitrypsin Deficiency
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||QUANTitative Chest Computed Tomography UnMasking Emphysema Progression in Alpha-1 Antitrypsin Deficiency|
- CT density slope [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
50 cc of serum at visits baseline, 6 months, 12 months, 18 months, 24 months and 36 months will be retained. These are kept at the University of Florida in the laboratory of Dr. Mark Brantly.
There is an associated but independent DNA collection that is done if the patient is willing through an independent study and consent process with the University of Florida Alpha-1 DNA and Tissue Bank. This is a public resource with a scientific advisory committee with samples available for researcher access.
|Study Start Date:||August 2007|
|Study Completion Date:||April 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
AAT deficiency is a genetic disorder associated with emphysema. Spirometry, the lung function test that measures how well the lungs exhale air, is used to diagnose and track the progression of emphysema. Some studies have suggested that forced expiratory volume in 1 second (FEV1) measurements, a type of spirometry test, may lack accuracy in detecting disease progression in cases of severe AAT deficiency. Another method, high resolution chest CT scans, may be more accurate at measuring the progression of emphysema. The purpose of this study is to determine if high resolution CT scans are better at detecting the progression of emphysema than lung function tests. Results from this study may lead to the development of a more accurate way to assess lung tissue loss and may improve the understanding of lung destruction in AAT deficiency.
This study will last 4 years and will enroll people with AAT deficiency who have nearly normal lung function test results. Study visits, each lasting about 4 hours, will occur at baseline and months 6, 12, 18, 24, and 36. At each visit, participants will undergo lung function tests, a CT scan, blood collection, and a physical exam. Female participants will have urine collected for a pregnancy test. All participants will also complete questionnaires to assess health status and lung function. Study researchers will call participants every 2 months to collect information on lung disease symptoms and medication changes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532805
|United States, Colorado|
|National Jewish Medical and Research Center|
|Denver, Colorado, United States|
|United States, Florida|
|University of Florida Medical Center|
|Gainesville, Florida, United States|
|United States, Massachusetts|
|Harvard/Brigham and Women's Hospital|
|Boston, Massachusetts, United States|
|United States, Ohio|
|Cincinnati Children's Medical Center|
|Cincinnati, Ohio, United States|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States|
|United States, Oregon|
|Oregon Health and Sciences University|
|Portland, Oregon, United States|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States|
|Study Chair:||Charlie Strange, MD||Medical University of South Carolina|