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

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ClinicalTrials.gov Identifier: NCT00214448
Recruitment Status : Unknown
Verified September 2005 by Abbott Molecular.
Recruitment status was:  Not yet recruiting
First Posted : September 22, 2005
Last Update Posted : July 14, 2006
Sponsor:
Information provided by:
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.

Condition or disease
Genetic Disorders

Study Type : Observational
Enrollment : 4 participants
Observational Model: Defined Population
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Reproducibility of the GeneTrait™ CGH Microarray System DX Using Whole Blood Samples




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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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): NCT00214448


Contacts
Contact: Lynda Hague 224-361-7101 lynda.hague@abbott.com
Contact: Andrew Hiar 224-361-7056 andrew.hiar@abbott.com

Sponsors and Collaborators
Abbott Molecular

ClinicalTrials.gov Identifier: NCT00214448     History of Changes
Other Study ID Numbers: 05-801
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: July 14, 2006
Last Verified: September 2005

Keywords provided by Abbott Molecular:
Multiple genetic conditions will be studied

Additional relevant MeSH terms:
Genetic Diseases, Inborn