Method Comparison and Clinical Specificity Study: Evaluation of the Infinium HD Cytogenetic Abnormality Test

Completed

• Conditions: Post-natal Cytogenetics

• Registration Number: NCT01426308
• Lead Sponsor: Illumina, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-29
• Study First Submitted QC: 2011-08-30
• Study First Posted: 2011-08-31
• Status Verified: 2011-09
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

ARUP Laboratories; 🇺🇸 Salt Lake City, Utah, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States