NCT00214448

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

July 14, 2006

Status Verified

September 1, 2005

First QC Date

September 20, 2005

Last Update Submit

July 13, 2006

Conditions

Genetic Disorders

Keywords

Multiple genetic conditions will be studied

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Lynda Hague

CONTACT

224-361-7101lynda.hague@abbott.com

Andrew Hiar

CONTACT

224-361-7056andrew.hiar@abbott.com

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Last Updated

July 14, 2006

Record last verified: 2005-09