NCT01160783

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
21mo left

Started Apr 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Apr 2007Feb 2028

Study Start

First participant enrolled

April 1, 2007

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2010

Completed
17.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

20.7 years

First QC Date

July 9, 2010

Last Update Submit

February 5, 2024

Conditions

Autism Spectrum DisorderAutismAsperger's SyndromePervasive Developmental Disorder

Keywords

AutismAsperger's SyndromeAsperger SyndromeAutistic DisorderAutism Spectrum DisorderPervasive Developmental DisordersPervasive Developmental Disorder-Not Otherwise SpecifiedChild Development Disorders, PervasivePDD-NOS

Outcome Measures

Primary Outcomes (1)

  • Gene expression levels

    Gene expression levels

    At sample collection

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, DNA and RNA and/or Saliva, DNA

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderAsperger SyndromeChild Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Christopher Walsh, MD, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Genetics & Genomics

Study Record Dates

First Submitted

July 9, 2010

First Posted

July 12, 2010

Study Start

April 1, 2007

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)