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| Tracking Information | |||||
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| First Received Date ICMJE | July 11, 2007 | ||||
| Last Updated Date | October 9, 2009 | ||||
| Start Date ICMJE | January 2001 | ||||
| Estimated Primary Completion Date | January 2050 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Structured questionnaire responses on the risks and benefits of testing. [ Time Frame: Before and after alpha-1 antitrypsin testing ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Structured questionnaire responses on the risks and benefits of testing. [ Time Frame: Before and after alpha-1 antitrypsin testing ] | ||||
| Change History | Complete list of historical versions of study NCT00500123 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Alpha-1 Coded Testing Study (ACT Trial) | ||||
| Official Title ICMJE | Alpha-1 Coded Testing Study (ACT Trial) | ||||
| Brief Summary | The Alpha-1 Coded Testing (ACT) Study was established to study genetic testing and outcomes of individuals at risk for alpha-1 antitrypsin deficiency. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Screening, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Alpha 1-Antitrypsin Deficiency | ||||
| Intervention ICMJE | Procedure: Alpha-1 Antitrypsin Genotype | ||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 25000 | ||||
| Estimated Completion Date | January 2050 | ||||
| Estimated Primary Completion Date | January 2050 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00500123 | ||||
| Responsible Party | Charlie Strange, M.D., Medical University of South Carolina | ||||
| Study ID Numbers ICMJE | HR 9556 | ||||
| Study Sponsor ICMJE | Medical University of South Carolina | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Medical University of South Carolina | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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