Alpha-1 Coded Testing Study (ACT Trial)

This study is currently recruiting participants.

Verified by Medical University of South Carolina, October 2009

First Received: July 11, 2007 Last Updated: October 9, 2009 History of Changes

Sponsor:	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

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)

Resource links provided by NLM:

Genetics Home Reference related topics: alpha-1 antitrypsin deficiency

MedlinePlus related topics: Alpha-1 Antitrypsin Deficiency

U.S. FDA Resources

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:

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

Additional Information:

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

Publications:

Carpenter MJ, Strange C, Jones Y, Dickson MR, Carter C, Moseley MA, Gilbert GE. Does genetic testing result in behavioral health change? Changes in smoking behavior following testing for alpha-1 antitrypsin deficiency. Ann Behav Med. 2007 Feb;33(1):22-8.

Strange C, Moseley MA, Jones Y, Schwarz L, Xie L, Brantly ML. Genetic testing of minors for alpha1-antitrypsin deficiency. Arch Pediatr Adolesc Med. 2006 May;160(5):531-4.

Strange C, Dickson R, Carter C, Carpenter MJ, Holladay B, Lundquist R, Brantly ML. Genetic testing for alpha1-antitrypsin deficiency. Genet Med. 2004 Jul-Aug;6(4):204-10.

Responsible Party:	Medical University of South Carolina ( Charlie Strange, M.D. )
Study ID Numbers:	HR 9556
Study First Received:	July 11, 2007
Last Updated:	October 9, 2009
ClinicalTrials.gov Identifier:	NCT00500123 History of Changes
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

Additional relevant MeSH terms:

Serine Proteinase Inhibitors
Protein C Inhibitor
Alpha 1-Antitrypsin
Molecular Mechanisms of Pharmacological Action
Alpha 1-Antitrypsin Deficiency

Trypsin Inhibitors
Connective Tissue Diseases
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on November 05, 2009