Alpha-1 Foundation DNA and Tissue Bank

Alpha 1 Antitrypsin Deficiency Clinical Trial

Official title:

Alpha-1 Foundation DNA and Tissue Bank

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00884455
• Other study ID #: IRB201500842 AATD Tissue Bank
• Status: Enrolling by invitation
• Start date: December 2002
• Est. completion date: June 10, 2033

Study information

• Verified date: August 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5000
• Est. completion date: June 10, 2033
• Est. primary completion date: June 10, 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all interested individuals may enroll

Exclusion Criteria:

• there are no exclusion criteria

Related Conditions & MeSH terms

• Alpha 1 Antitrypsin Deficiency
• Alpha 1-Antitrypsin Deficiency

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Alpha-1 Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

Clark VC, Dhanasekaran R, Brantly M, Rouhani F, Schreck P, Nelson DR. Liver test results do not identify liver disease in adults with alpha(1)-antitrypsin deficiency. Clin Gastroenterol Hepatol. 2012 Nov;10(11):1278-83. doi: 10.1016/j.cgh.2012.07.007. Epu — View Citation

Tonelli AR, Rouhani F, Li N, Schreck P, Brantly ML. Alpha-1-antitrypsin augmentation therapy in deficient individuals enrolled in the Alpha-1 Foundation DNA and Tissue Bank. Int J Chron Obstruct Pulmon Dis. 2009;4:443-52. doi: 10.2147/copd.s8577. Epub 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data and tissue samples	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.	The total number of tissue samples received and used for research are tracked annually.