Genetic Contributions to Autism Spectrum Disorders
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 9, 2010 | ||||
| Last Updated Date | February 11, 2013 | ||||
| Start Date ICMJE | April 2007 | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Gene expression levels [ Time Frame: At sample collection ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01160783 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Genetic Contributions to Autism Spectrum Disorders | ||||
| Official Title ICMJE | Genetic Contributions to Autism Spectrum Disorders | ||||
| 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. |
||||
| 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 ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Family-Based Time Perspective: Cross-Sectional |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Whole blood, DNA and RNA and/or Saliva, DNA |
||||
| 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 |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 1500 | ||||
| Estimated Completion Date | December 2015 | ||||
| Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Months and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01160783 | ||||
| Other Study ID Numbers ICMJE | 07-04-0136 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Children's Hospital Boston | ||||
| Study Sponsor ICMJE | Children's Hospital Boston | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Children's Hospital Boston | ||||
| Verification Date | February 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||