Method Comparison and Clinical Specificity Study: Evaluation of the Infinium HD Cytogenetic Abnormality Test
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|ClinicalTrials.gov Identifier: NCT01426308|
Recruitment Status : Completed
First Posted : August 31, 2011
Last Update Posted : April 28, 2016
The study will determine the performance of the Infinium HD Test.
- The primary objective of the study is to assess the performance of the Infinium HD Test using banked DNA samples extracted from whole blood patient samples derived from the intended use population.
- The secondary objective of the study is to determine the background number of chromosomal abnormalities per person in the general population based on the resolution of the Infinium HD Test.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||900 participants|
|Official Title:||Method Comparison and Clinical Specificity Study: Evaluation of the Infinium HD Cytogenetic Abnormality Test|
|Study Start Date :||August 2011|
|Primary Completion Date :||November 2011|
|Study Completion Date :||November 2011|
Method Comparison Group
The method comparison group will consist of de-identified, leftover DNA samples from patients referred for post-natal cytogenetic testing.
Clinical Specificity Group
The clinical specificity group will consist of de-identified, leftover DNA samples from non-phenotypic patients, or patients not referred for post-natal cytogenetic testing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426308
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29403|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77021|
|United States, Utah|
|Salt Lake City, Utah, United States, 84108|