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Genetic Contributions to Autism Spectrum Disorders

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: NCT01160783
Recruitment Status : Active, not recruiting
First Posted : July 12, 2010
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Ingrid Holm, Boston Children's Hospital

Brief Summary:
This study is working towards gaining a better understanding of the genetic and environmental factors involved in autism spectrum disorders (ASD), which includes autism, pervasive developmental disorder (PDD), and Asperger's syndrome. The investigators hope that information gained from this study will lead to new ways of diagnosing and treating ASDs.

Condition or disease
Autism Spectrum Disorder Autism Asperger's Syndrome Pervasive Developmental Disorder

Detailed Description:
Participation generally takes less than 2 hours to complete and travel to Children's Hospital Boston is not required. Participants are asked some questions about their medical and family history. The investigators also request permission to review medical records related to the ASD diagnosis. Finally, the investigators obtain a small blood or saliva sample in order to search for genes that may be important in understanding ASD. The investigators can arrange for the blood draw through a participant's physician or a clinical laboratory and saliva samples can be obtained through the mail. The study questions are answered via telephone or mailed questionnaires. There is no cost to participate.

Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Genetic Contributions to Autism Spectrum Disorders
Study Start Date : April 2007
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Gene expression levels [ Time Frame: At sample collection ]

Biospecimen Retention:   Samples With DNA
Whole blood, DNA and RNA and/or Saliva, DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with a diagnosis of an Autism Spectrum Disorder (autism, pervasive developmental disorder (PDD), or Asperger's syndrome) and their parents and/or siblings
Criteria

Inclusion Criteria:

  • Clinical diagnosis of an Autism Spectrum Disorder (autism, pervasive developmental disorder (PDD), or Asperger's syndrome)
  • Age > 18 months

Exclusion Criteria:

  • Do not have the diagnosis of an ASD
  • Participation in the "Phenotypic and Genetic Risk Factors in ASD" study at Boston Children's Hospital.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160783


Locations
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
Principal Investigator: Ingrid A Holm, MD, MPH Boston Children’s Hospital

Responsible Party: Ingrid Holm, Associate Physician in Medicine;Associate Professor of Pediatrics, Harvard Medical School, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01160783     History of Changes
Other Study ID Numbers: 07-04-0136
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ingrid Holm, Boston Children's Hospital:
Autism
Asperger's Syndrome
Asperger Syndrome
Autistic Disorder
Autism Spectrum Disorder
Pervasive Developmental Disorders
PDD-NOS
Child Development Disorders, Pervasive
Pervasive Developmental Disorder-Not Otherwise Specified

Additional relevant MeSH terms:
Disease
Syndrome
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Developmental Disabilities
Asperger Syndrome
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders