Clinical Protocol SeCore, uTYPE and 3500 Dx System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Life Technologies Corporation
ClinicalTrials.gov Identifier:
NCT01285427
First received: January 12, 2011
Last updated: April 15, 2014
Last verified: April 2014
Results First Received: May 8, 2013  
Study Type: Observational
Study Design: Observational Model: Case-Only
Condition: Human Leukocyte Antigens (HLA)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Not applicable. De-identified, archived whole blood samples

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not Applicable

Reporting Groups
  Description
DNA Loci (SeCore vs. SSP UniTray Platforms) No text entered.

Participant Flow:   Overall Study
    DNA Loci (SeCore vs. SSP UniTray Platforms)  
STARTED     300  
COMPLETED     299 [1]
NOT COMPLETED     1  
[1] One sample be discarded per FDA, sample drawn with heparin tube, not specified in protocol.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DNA Loci (SeCore vs. SSP UniTray Platforms) No text entered.

Baseline Measures
    DNA Loci (SeCore vs. SSP UniTray Platforms)  
Number of Participants  
[units: participants]
  300  
Age  
[units: participants]
 
<=18 years     NA [1]
Between 18 and 65 years     NA [2]
>=65 years     NA [2]
Age  
[units: years]
Mean ± Standard Deviation
  NA  ± NA [1]
Gender  
[units: participants]
 
Female     NA [1]
Male     NA [1]
de-identified whole blood samples  
[units: participants]
  300  
[1] Not Applicable, De-identified leftover blood samples
[2] Not Applicable, De-identified whole blood samples



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI)   [ Time Frame: 10 weeks ]

2.  Primary:   SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)   [ Time Frame: 10 weeks ]

3.  Primary:   SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI)   [ Time Frame: 10 weeks ]

4.  Primary:   SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)   [ Time Frame: 10 weeks ]

5.  Primary:   SeCore® Kit, DPB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)   [ Time Frame: 10 weeks ]

6.  Primary:   SeCore® Kit, DQB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)   [ Time Frame: 10 weeks ]

7.  Primary:   SeCore® Kit, DRB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)   [ Time Frame: 10 weeks ]

8.  Primary:   SeCore® Kit, DR Group Kit (DRB1 Locus), Primary Analysis of Concordance Rate (CI)   [ Time Frame: 10 weeks ]

9.  Primary:   SeCore® Kit, DR Group Kit (DRB345 Loci), Primary Analysis of Concordance Rate Clopper-Pearson CI)   [ Time Frame: 10 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Deanna Vella, Staff Regulatory Engineer
Organization: Life Technologies
phone: 760-918-3000
e-mail: deanna.vella@lifetech.com


No publications provided


Responsible Party: Life Technologies Corporation
ClinicalTrials.gov Identifier: NCT01285427     History of Changes
Other Study ID Numbers: DMR0000279
Study First Received: January 12, 2011
Results First Received: May 8, 2013
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration