NCT01677663

Brief Summary

Autism or autism spectrum disorder (ASD) is a relatively common (0.3% in Taiwan), multi-factorial, genetically and clinically heterogeneous, childhood-onset neurodevelopmental disorder. Due to its high heritability and severe long-term impairment without available laboratory diagnosis, effective prevention or treatment, this disastrous disease has been prioritized for molecular genetic studies. Recent CNVs investigation to identify rare variants and GWA study with endophenotype approaches are promising strategies to identify common genetic variants. In addition to intermediate phenotypes such as head circumstance, speech delay, social impairments and stereotyped behaviors, evidence has demonstrated that neuropsychology and neuroimages may be useful endophenotypes for autism. Dlgap2, Fbxo25, and Arhgef10 knoutout mice generated from our previous CNV results will be characterized.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

First QC Date

August 30, 2012

Last Update Submit

August 31, 2012

Conditions

Keywords

autismclinical phenotypesneuropsychologyimaging endophenotypesfamily-based cohortknoutout mice

Eligibility Criteria

Age3 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The sample will consist of 350 probands with ASD, aged 3-25.

You may qualify if:

  • subjects have a clinical diagnosis of autistic disorder or Asperger disorder defined by the DSM-IV and ICD-10;
  • their ages range from 3 to 25 when we conduct the study;
  • subjects have at least one biological parent;
  • both parents of the subjects are Han Chinese;
  • subjects and their biological parents (and siblings if any) consent to participate in this study.

You may not qualify if:

  • if they currently meet criteria or have a history of DSM-IV Schizophrenia, Schizoaffective Disorder, or Organic Psychosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The subjects will receive blood withdrawal. The blood sample will be used for establishing lymphoblastoid cell lines, which will be used for molecular genetic experiments.

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Susan Shur-Fen Gau, MD, PhD

    National Taiwan University Hospital & College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Shur-Fen Gau, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Susan Shur-Fen Gau

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 3, 2012

Study Start

August 1, 2011

Study Completion

July 1, 2016

Last Updated

September 3, 2012

Record last verified: 2012-08

Locations