Autism Clinical Trial
Official title:
Studies of Autistic Patients: Gene Networks and Clinical Subtypes
Verified date | September 24, 2013 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- Researchers who are studying autism spectrum disorders are interested in developing a
collection of research samples from both children with autism and healthy individuals,
some of whom may be related to the children with autism.
- The genetic condition tuberous sclerosis, which can cause the growth of benign tumors in
the brain and other parts of the body, is also linked with autism. Researchers have been
able to determine the specific genetic mutations involved in tuberous sclerosis, and as
a result are interested in studying the genetic information of children who have both
tuberous sclerosis and autism, as well as tuberous sclerosis without autism.
Objectives:
- To develop a collection of DNA samples from blood and skin samples taken from children with
autism and/or tuberous sclerosis, as well as healthy volunteers.
Eligibility:
- Children between 4 to 18 years of age who have autism and/or tuberous sclerosis, or are
healthy volunteers.
- Some of the healthy volunteers will be siblings of children with autism.
Design:
- Participants will be screened with a medical history and a physical examination, and may
also have a genetic evaluation.
- Participants will provide a blood sample and a skin biopsy for further study.
- No treatment will be provided as part of this protocol.
Status | Terminated |
Enrollment | 11 |
Est. completion date | September 24, 2013 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 4 Years to 18 Years |
Eligibility |
- INCLUSION CRITERIA: Autism Groups: Meeting criteria for a diagnosis of autism, based on the Autism Diagnostic Interview-Revised and the Autism Diagnostic Observation Schedule, as well as clinical judgment. Health Sibling and Typically Developing Group: Within 1.5 standard deviations from the mean on the cognitive test performed, and lower than the cutoff scores on the Autism Diagnostic Interview and Autism Diagnostic Observation Schedule, and not meeting criteria for any psychiatric disorder on interviews or questionnaires. Tuberous Sclerosis Groups: Confirmed diagnosis of Tuberous Sclerosis EXCLUSION CRITERIA: Autism Groups: Non-idiopathic autism (e.g. previously identified genetic abnormality associated with autism in that individual) Typically Developing Group: History of receiving a diagnosis or services for psychiatric or significant learning issues |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Levitt P, Campbell DB. The genetic and neurobiologic compass points toward common signaling dysfunctions in autism spectrum disorders. J Clin Invest. 2009 Apr;119(4):747-54. doi: 10.1172/JCI37934. Epub 2009 Apr 1. Review. — View Citation
Sendtner M. Stem cells: Tailor-made diseased neurons. Nature. 2009 Jan 15;457(7227):269-70. doi: 10.1038/457269a. — View Citation
Yonan AL, Palmer AA, Smith KC, Feldman I, Lee HK, Yonan JM, Fischer SG, Pavlidis P, Gilliam TC. Bioinformatic analysis of autism positional candidate genes using biological databases and computational gene network prediction. Genes Brain Behav. 2003 Oct;2(5):303-20. — View Citation
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