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Alpha-1 Foundation DNA and Tissue Bank

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: NCT00884455
Recruitment Status : Enrolling by invitation
First Posted : April 20, 2009
Last Update Posted : September 21, 2022
Sponsor:
Collaborator:
Alpha-1 Foundation
Information provided by (Responsible Party):
University of Florida

Study Description
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Brief Summary:
This is a long-term follow-up banking protocol that collects medical information and tissue (blood, liver and lung) samples for future research; use of data and samples for research purposes is overseen by the Tissue Bank Advisory Committee; the purpose of the Bank is to further research on alpha-1 antitrypsin deficiency.

Condition or disease
Alpha 1 Antitrypsin Deficiency

Detailed Description:

Subject participation includes completion of informed consent, medical questionnaire, and email authorization. Subjects may provide a blood sample for alpha-1 antitrypsin genotype, phenotype and level. Lung and liver tissue may also be provided if available. Subjects may be contacted no more often than annually for updated information.

This project has a certificate of confidentiality from NIH.

Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Alpha-1 Foundation DNA and Tissue Bank
Actual Study Start Date : December 2002
Estimated Primary Completion Date : June 10, 2023
Estimated Study Completion Date : June 10, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Data and tissue samples [ Time Frame: The total number of tissue samples received and used for research are tracked annually. ]
    At the end of 15 years the tissue and data sample usage will be analyzed to determine continuation of the project. Each year the investigator provides a summary to the Alpha-1 Foundation.


Biospecimen Retention:   Samples With DNA
blood, liver and lung

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
subjects with alpha-1-antitrypsin deficiency, carriers of deficient alleles and interested individuals
Criteria

Inclusion Criteria:

  • all interested individuals may enroll

Exclusion Criteria:

  • there are no exclusion criteria
Contacts and Locations
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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): NCT00884455


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Alpha-1 Foundation
Investigators
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Principal Investigator: Mark L Brantly, MD University of Florida
More Information
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Publications of Results:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00884455    
Other Study ID Numbers: IRB201500842 AATD Tissue Bank
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Keywords provided by University of Florida:
tissue banking, research
Additional relevant MeSH terms:
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Alpha 1-Antitrypsin Deficiency
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
 Genetic Diseases, Inborn
Subcutaneous Emphysema
Emphysema
Pathologic Processes