NCT01749670

Brief Summary

There is accumulating evidence that genetic expression plays a role in autism spectrum disorder, but the regulation of such genes is poorly understood. Small RNA particles, called microRNA (miRNA), have the ability to alter gene expression. These particles can be packaged and released from brain cells into the blood. Changes in miRNA may contribute to the patterns observed in autism spectrum disorder. The purpose of this study is to identify small RNA particles that regulate gene expression in autism spectrum disorder. The goal is to identify miRNA expression patterns which may improve our understanding and diagnosis of autism spectrum disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

December 12, 2012

Last Update Submit

November 25, 2014

Conditions

Keywords

Autism Spectrum DisorderExosomal miRNA expression

Outcome Measures

Primary Outcomes (1)

  • Exosomal microRNA expression patterns

    1 day

Study Arms (2)

Autism

Children ages 4-17 years old with DSM-IV defined autism spectrum disorder

Control

Age- and gender-matched controls with typical neuropsychological developmental patterns

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children from the University Pediatric and Adolescent Center and the Center for Development Behavior and Genetics in Syracuse, New York.

You may qualify if:

  • Children ages 4-17

You may not qualify if:

  • neurological impairments (i.e. cerebral palsy, epilepsy)
  • sensory deficits (i.e. sensory or visual impairments)
  • psychological disorders (i.e. obsessive compulsive disorder, attention deficit disorder)
  • control subjects with family history of autism spectrum disorder
  • mental retardation
  • history of preterm birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Steven Hicks, MD, PhD

    SUNY Upstate Medical University, Department of Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2012

First Posted

December 17, 2012

Study Start

January 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 26, 2014

Record last verified: 2014-11

Locations