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NCT00214448 Clinical Trial

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

Genetic Disorders Clinical Trial

Official title:
Reproducibility of the GeneTrait™ CGH Microarray System DX Using Whole Blood Samples

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00214448
Other study ID # 05-801
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 20, 2005
Last updated July 13, 2006

Study information
Verified date September 2005
Source Abbott Molecular
Contact Lynda Hague
Phone 224-361-7101
Email lynda.hague@abbott.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 4
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Abbott Molecular
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