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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01160783
Other study ID # 07-04-0136
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 2007
Est. completion date February 2028

Study information

Verified date February 2024
Source Boston Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 240
Est. completion date February 2028
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 18 Months and older
Eligibility 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.

Study Design


Locations

Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gene expression levels Gene expression levels At sample collection
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