Status:
COMPLETED
Evaluating the Validity of a Genetic Risk Assessment Tool in Identifying Autism Spectrum Disorder
Lead Sponsor:
Thomas W. Frazier, Ph.D
Collaborating Sponsors:
IntegraGen SA
Conditions:
Autism Spectrum Disorder
Attention Deficit/Hyperactivity Disorder
Eligibility:
All Genders
1-12 years
Brief Summary
There are three purposes to this study. The first purpose is to evaluate the value of a genetic test in determining risk for autism spectrum disorder. Processing for genetic samples will be completed ...
Eligibility Criteria
Inclusion
- Diagnosis of Autistic Disorder, Pervasive Developmental Disorder, or Asperger's Disorder or have a clinical diagnosis of another developmental or psychiatric disorder (developmental/psychiatric controls), or have no specific developmental or psychiatric diagnosis (healthy controls).
- Age 1 to 12.
Exclusion
- For individuals with ASD and developmental concern controls, presence of a known or strongly suspected genetic disorder based on all available clinical data.
- Age less than 1 or greater than 12.
- Individuals for whom DNA is not available for analysis.
- Individuals for whom it is anticipated that they will not be available for follow-up at the Cleveland Clinic during the study period.
- Any medical diagnoses that might preclude participation in a low risk, non-interventional research study and any participant who at the discretion of the clinical investigator is not medically able to participate in the study (e.g., unable to comply with cheek swab or other procedure or has serious medical condition which precludes participation).
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT01452061
Start Date
January 1 2012
End Date
December 1 2013
Last Update
January 29 2014
Active Locations (1)
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1
Cleveland Clinic Center for Autism
Cleveland, Ohio, United States, 44104