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Alpha-1 Coded Testing Study (ACT Trial)

This study is currently recruiting participants.
Verified by Medical University of South Carolina, July 2008

Sponsored by: Medical University of South Carolina
Information provided by: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00500123
  Purpose

The Alpha-1 Coded Testing (ACT) Study was established to study genetic testing and outcomes of individuals at risk for alpha-1 antitrypsin deficiency.


Condition Intervention
Alpha 1-Antitrypsin Deficiency
Procedure: Alpha-1 Antitrypsin Genotype

Genetics Home Reference related topics:   alpha-1 antitrypsin deficiency   

MedlinePlus related topics:   Alpha-1 Antitrypsin Deficiency   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Screening, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Alpha-1 Coded Testing Study (ACT Trial)

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Structured questionnaire responses on the risks and benefits of testing. [ Time Frame: Before and after alpha-1 antitrypsin testing ] [ Designated as safety issue: No ]

Estimated Enrollment:   25000
Study Start Date:   January 2001
Estimated Study Completion Date:   January 2050
Estimated Primary Completion Date:   January 2050 (Final data collection date for primary outcome measure)

Intervention Details:
    Procedure: Alpha-1 Antitrypsin Genotype
    Fingerstick testing for Alpha-1 Antitrypsin Genotype
Detailed Description:

Genetic testing for alpha-1 antitrypsin deficiency is sometimes delayed despite established testing indications. All genetic tests have risks and possible benefits. The ACT study evaluates the population demographics, reasons for testing, and outcomes through a confidential testing program. Concerns about genetic confidentiality are lessened in this study by a coded testing procedure that returns results through the mail to study participants. Outcomes of testing are recorded.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Individuals at risk for Alpha-1 Antitrypsin Deficiency
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500123

Contacts
Contact: Charlie Strange, M.D.     843-792-0260     alphaone@musc.edu    

Locations
United States, South Carolina
Medical University of South Carolina. Division of Pulmonary and Critical Care Medicine     Recruiting
      Charleston, South Carolina, United States, 29425

Sponsors and Collaborators
Medical University of South Carolina

Investigators
Principal Investigator:     Charlie Strange, M.D.     Medical University of South Carolina    
  More Information


Alpha-1 Coded Testing Link  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Responsible Party:   Medical University of South Carolina ( Charlie Strange, M.D. )
Study ID Numbers:   HR 9556
First Received:   July 11, 2007
Last Updated:   July 18, 2008
ClinicalTrials.gov Identifier:   NCT00500123
Health Authority:   United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
alpha-1  
antitrypsin  
AAT  
genetic testing
alpha-1 antitrypsin deficiency
AATD

Study placed in the following topic categories:
Protein C Inhibitor
Alpha 1-Antitrypsin
Protein C
Alpha 1-Antitrypsin Deficiency
Alpha 1-antitrypsin deficiency
Connective Tissue Diseases

Additional relevant MeSH terms:
Serine Proteinase Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008




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