Alpha-1 Foundation DNA and Tissue Bank

• Conditions: Alpha 1 Antitrypsin Deficiency

• Registration Number: NCT00884455
• Lead Sponsor: University of Florida

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.

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 Timeline

• Study Start: 2002-12
• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2032-06-10
• Study Completion: 2033-06-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• all interested individuals may enroll

Exclusion Criteria

• there are no exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Data and tissue samples	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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States