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Enrolling by invitationNCT00884455Updated Jan 15, 2026

Alpha-1 Foundation DNA and Tissue Bank

An observational study in Alpha 1 Antitrypsin Deficiency, sponsored by University of Florida. Enrolling by invitation at 1 site in United States. Open to participants aged 0 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-15.

Sponsored by University of Florida · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
5,000
Ages
0 Years to 100 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Alpha 1 Antitrypsin Deficiency

Keywords

  • tissue banking, research
03

In context

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Years to 100 Years
Sexes eligible
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

Inclusion criteria

  • all interested individuals may enroll

Exclusion criteria

Exclusion Criteria:

  • there are no exclusion criteria
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: The total number of tissue samples received and used for research are tracked annually.

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Study locations

1 site
  • University of Florida
    Gainesville, Florida 32610, United States
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References and documents

Publications

  • 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 2009 Dec 29. PubMed 20054436 ↗
  • 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. Epub 2012 Jul 24. PubMed 22835581 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00884455
Lead sponsor
University of Florida
Collaborators
Alpha-1 Foundation
Responsible party
Sponsor
First posted
Apr 20, 2009
Start date
Dec 2002
Primary completion
Jun 10, 2032 (estimated)
Completion
Jun 10, 2033 (estimated)
Last update
Jan 15, 2026

Study contacts

Karina Serban, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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