- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01451983
Genetics, Brain Structure and Thinking Skills in Autism
January 7, 2015 updated by: Thomas W. Frazier, Ph.D, The Cleveland Clinic
Genetic, Biochemical, Behavioral and Neuroimaging Phenotypes of Autism Spectrum Disorders (ASDs)
The purpose of this research is to better understand the genetic, biochemical, cognitive and behavioral symptom abnormalities that contribute to autism spectrum disorders.
The investigators anticipate recruiting at least 100 participants with autism spectrum disorder and large head size, at least 100 participants with autism spectrum disorder without large head size and at least 40 healthy siblings.
Biological parents are expected to be recruited only as genetic changes are identified in individuals with autism spectrum disorders to better understand the nature of these genetic changes.
Participants are asked to complete cognitive testing, a blood draw, urine collection and measurement of his/her height, weight and head circumference.
Parents or caregivers may be asked to complete a diagnostic evaluation and will complete questionnaires that examine the participant's medical and family history as well as his/her current symptoms, functioning, and quality of life.
A brief report simply listing and giving a basic description of any behavioral diagnostic information, autism symptoms, adaptive functioning, and a listing of results from cognitive testing will be provided as part of this study.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
138
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44104
- Cleveland Clinic Center for Autism
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
We anticipate recruiting 80 participants with autism spectrum disorder and large head size, 80 participants with autism spectrum disorder without large head size and 40 healthy siblings.
Biological parents are expected to be recruited only as genetic changes are identified in individuals with autism spectrum disorders to better understand the nature of these genetic changes.
Description
Inclusion Criteria:
- Clinical diagnosis of autism
- Consent from parents or guardians or an adult with or suspected of having an autism spectrum disorder that does not require a legal guardian or an adult who is the healthy sibling of an individual with an autism spectrum disorder.
- Youth ages 2-17 and adults ages 18-50. Youths and adults who are able (some young or severely impaired participants may not be able to provide assent) will be asked to provide assent.
- Families with multiple children who meet the above inclusion criteria will be permitted to have as many children participate as they wish.
- Youth ages 2-17 and adults ages 18-50 who do not have an autism spectrum disorder or are not suspected of having an autism spectrum disorder and who have a sibling with an autism spectrum disorder who has participated in the present study.
Exclusion Criteria:
- Clinically significant medical disease that would prohibit participation in the study procedures.
- Children younger than 2 years old and adults older than 50 years old.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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ASD with PTEN
Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
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ASD no PTEN macrocephaly
Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
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ASD no PTEN no macrocephaly
Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
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Siblings
Siblings of individuals with autism spectrum disorders.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Total Brain Volume
Time Frame: Baseline
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas W Frazier, Ph.D., The Cleveland Clinic
- Principal Investigator: Charis Eng, M.D., Ph.D., The Cleveland Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
October 11, 2011
First Submitted That Met QC Criteria
October 13, 2011
First Posted (Estimate)
October 14, 2011
Study Record Updates
Last Update Posted (Estimate)
January 14, 2015
Last Update Submitted That Met QC Criteria
January 7, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCF 09-624
- UL1RR024989 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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