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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date September 20, 2005
First Posted Date September 22, 2005
Last Update Posted Date July 14, 2006
Study Start Date Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00214448 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Reproducibility of the Array-Based Comparative Genomic Hybridization (aCGH) System Using Whole Blood Samples
Official Title Reproducibility of the GeneTrait™ CGH Microarray System DX Using Whole Blood Samples
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 Provided
Study Type Observational
Study Design Observational Model: Defined Population
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Genetic Disorders
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Enrollment
 (submitted: September¬†20,¬†2005)
4
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00214448
Other Study ID Numbers 05-801
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Abbott Molecular
Collaborators Not Provided
Investigators Not Provided
PRS Account Abbott Molecular
Verification Date September 2005