Clinical Protocol SeCore, uTYPE and 3500 Dx System

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2011 by Life Technologies Corporation.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Life Technologies Corporation

ClinicalTrials.gov Identifier:

NCT01285427

First received: January 12, 2011

Last updated: February 3, 2011

Last verified: February 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	January 12, 2011
Last Updated Date	February 3, 2011
Start Date ^ICMJE	January 2011
Estimated Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 26, 2011)	Identification and definition of Class I and Class II HLAs [ Time Frame: 6 Months ] [ Designated as safety issue: No ] To compare the Invitrogen SeCore sequencing kits with uTYPE to the predicate device Invitrogen SSP UniTray kits with UniMatch so as to show 95% concordance with 90% confidence.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01285427 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Protocol SeCore, uTYPE and 3500 Dx System
Official Title ^ICMJE	SeCore Sequencing Kit and 3500xl Dx Genetic Analyzer Clinical Performance Testing vs. SSP UniTray
Brief Summary	The purpose of this study is to compare the Invitrogen SeCore(R) sequencing system and uTYPE(R) interpretation software to the predicate device Invitrogen SSP UniTray(R) with UniMatch(R) interpretation software and show 95% concordance with 90% confidence.
Detailed Description	Testing will be performed on A, B, C, DRB1, DRB3/4/5, DQB1, and DPB1 loci. Additionally, testing will be performed using the following locus specific Group Specific Sequencing Primers: A, B, Cw, DPB1, DQB1 and DRB.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: DNA isolated from whole blood samples
Sampling Method	Non-Probability Sample
Study Population	A, B, C, DRB1, DRB3/4/5, DQB1, DPB1 loci
Condition ^ICMJE	Human Leukocyte Antigens (HLA)
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	DNA loci (SeCore vs. SSP UniTray platforms)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	300
Estimated Completion Date	May 2011
Estimated Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Deidentified leftover blood samples
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01285427
Other Study ID Numbers ^ICMJE	DMR0000279
Has Data Monitoring Committee	No
Responsible Party	Deanna Vella, Staff Regulatory Engineer, Life Technologies
Study Sponsor ^ICMJE	Life Technologies Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Life Technologies Corporation
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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