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

Sponsor
Abbott Molecular (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00214448
Collaborator
(none)
4
Enrollment

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

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

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      0 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Abbott Molecular

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00214448
      Other Study ID Numbers:
      • 05-801
      First Posted:
      Sep 22, 2005
      Last Update Posted:
      Jul 14, 2006
      Last Verified:
      Sep 1, 2005
      Keywords provided by , ,
      Multiple genetic conditions will be studied
      Additional relevant MeSH terms:
      Genetic Diseases, Inborn

      Study Results

      No Results Posted as of Jul 14, 2006