Method Comparison and Clinical Specificity Study: Evaluation of the Infinium HD Cytogenetic Abnormality Test
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: August 29, 2011
Last updated: September 26, 2011
Last verified: September 2011
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Method Comparison and Clinical Specificity Study: Evaluation of the Infinium HD Cytogenetic Abnormality Test|
Resource links provided by NLM:
Further study details as provided by Illumina, Inc.:
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||November 2011|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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|
Sponsors and Collaborators