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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Abbott Molecular.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Abbott Molecular
ClinicalTrials.gov Identifier:
NCT00214448
First received: September 20, 2005
Last updated: July 13, 2006
Last verified: September 2005
  Purpose

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
Genetic Disorders

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

Further study details as provided by Abbott Molecular:

Estimated Enrollment: 4
  Eligibility

Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00214448     History of Changes
Other Study ID Numbers: 05-801
Study First Received: September 20, 2005
Last Updated: July 13, 2006
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 11, 2014