Reproducibility of the Array-Based Comparative Genomic Hybridization (aCGH) System Using Whole Blood Samples

• Conditions: Genetic Disorders

• Registration Number: NCT00214448
• Lead Sponsor: Abbott Molecular

Brief Summary

The objective of this study is to validate the performance characteristics of the GeneTrait CGH Microarray System DX. Reproducibility among sites, lots, and operators will be evaluated.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-09
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Last Update Submitted: 2006-07-13
• Last Update Posted: 2006-07-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Must be able to donate at least 10 mL of whole blood
• Must be able to provide consent, or parental consent and patient assent (if applicable)
• Must be currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites
• Must have at least one chromosomal change that is detectable by the GeneTrait CGH Microarray System DX as determined by karyotype and/or fluorescence in situ hybridization (FISH) analysis (within any of the 73 critical regions)

Exclusion Criteria

• Unable to donate at least 10 mL of whole blood
• Unable to provide consent, or parental consent and patient assent (if applicable)
• Not currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites
• Does not have at least one chromosomal change that is detectable by the GeneTrait CGH Microarray System DX as determined by karyotype and/or FISH analysis (within any of the 73 critical regions)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified