SynapDx Autism Gene Expression Analysis Study (STORY)

This study is currently recruiting participants.
Verified January 2014 by SynapDx
Sponsor:
Information provided by (Responsible Party):
SynapDx
ClinicalTrials.gov Identifier:
NCT01810341
First received: March 11, 2013
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

This study will prospectively enroll approximately 880 children, at least 18 months and less than 60 months of age, who have been referred to a pediatric developmental evaluation center. Enrolled children will have blood drawn for RNA gene expression analysis and undergo a clinical evaluation to determine the presence or absence of a diagnosis of ASD.

The primary objective of this study is:

- To develop an algorithm to classify blood RNA gene expression patterns to maximize agreement between the classification and a clinical assessment of presence or absence of Autism Spectrum Disorders (ASD).


Condition
Autism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SynapDx Autism Spectrum Disorder Gene Expression Analysis Study

Resource links provided by NLM:


Further study details as provided by SynapDx:

Primary Outcome Measures:
  • RNA gene expression in peripheral blood [ Time Frame: Within 30 days of collection ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Peripheral blood


Estimated Enrollment: 880
Study Start Date: March 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Development Group
In the Development Phase, analyses will be performed until the classification algorithm is finalized.
Validation Group
The Validation Phase will assess the performance of the finalized classification algorithm in 300 subjects.

  Eligibility

Ages Eligible for Study:   18 Months to 60 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children 18 months to less than 60 months referred to a developmental evaluation center for evaluation of a possible developmental disorder.

Criteria

Inclusion Criteria:

  • Referred to a developmental evaluation center for evaluation of a possible developmental disorder, other than isolated motor problems.
  • At least 18 months and less than 60 months.
  • Parent/legal guardian has been informed about the study and has signed an informed consent form.

Exclusion Criteria:

  • Prior reliable diagnosis of Autism Spectrum Disorder (i.e. prior evaluation by a multi-disciplinary team has already reliably established Autism Spectrum Disorder diagnosis).
  • Unable or unwilling to complete study procedures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01810341

  Hide Study Locations
Locations
United States, Arizona
Melmed Center Recruiting
Scottsdale, Arizona, United States, 85254
Contact: Craig Ciuk    480-443-0050 ext 324    craig.ciuk@melmedcenter.com   
Principal Investigator: Raun Melmed, MD         
United States, California
Miller Children's Hospital Recruiting
Long Beach, California, United States, 90806
Contact: Nan O'Donnell, MS/RN    562-933-5607    nodonnell@memorialcare.org   
Principal Investigator: Feldman Gary, MD         
UC Davis MIND Institute Recruiting
Sacramento, California, United States, 95817
Contact: Jonathan Polussa    916-703-0477    jonathan.polussa@ucdmc.ucdavis.edu   
Principal Investigator: Kathleen Angkustsiri, MD         
United States, Georgia
Emory University Recruiting
Decatur, Georgia, United States, 30033
Contact: Meagan Smith    404-778-8528    meagan.smith@emoryhealthcare.org   
Principal Investigator: Jeannie Visootsak, MD         
United States, Illinois
Rush Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Rosa Figueroa    312-942-3034    rosa_figueroa@rush.edu   
Contact: Crystal Harvey    312-942-7250    Crystal_Hervey@rush.edu   
Principal Investigator: Cesar Ochoa-Lubinoff, MD         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Arlene Kohn    317-944-1990    aekohn@iupui.edu   
Contact: Dawn Graham       dlawrenc@iupui.edu   
Principal Investigator: Tom Lock, MD         
Principal Investigator: Kimberly Stigler, MD         
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sarah Weas    857-218-5328    Sarah.Weas@childrens.harvard.edu   
Principal Investigator: William Barbaresi, MD         
Lurie Center Massachusetts General Hospital Recruiting
Lexington, Massachusetts, United States, 02421
Contact: Jennifer Mullette, RN    781-860-1710    jmullett@partners.org   
Principal Investigator: Ann Neumeyer, MD         
United States, New York
Mount Sinai School of Medicine/Seaver Center Recruiting
New York, New York, United States, 10029
Contact: Sarah Soffes    212-241-2993    Sarah.soffes@mssm.edu   
Principal Investigator: Alex Kolevzon, MD         
Institute for Behavioral Research on Staten Island Recruiting
Staten Island, New York, United States, 10314
Contact: Anne Gordon    718-494-5122    anne.gordon@opwdd.ny.gov   
Principal Investigator: Ted Brown, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Lindsey Hazzard    919-972-7440    lindsey_hazzard@med.unc.edu   
Contact: Kristine Bayulot    919-972-7497    kristine_baluyot@med.unc.edu   
Principal Investigator: Linmarie Sikich, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Teri Maraan    513-803-3582    Teri.Maraan@cchmc.org   
Contact: Katherine Friedmann       katherine.friedmann@cchmc.org   
Principal Investigator: Logan Wink, MD         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Thomas Whitlow    614-355-8389    thomas.whitlow@nationwidechildrens.org   
Principal Investigator: Dan Coury, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sara Nguyen, MPH    267-426-7165    nguyens2@email.chop.edu   
Principal Investigator: Susan Levy, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Patricia Infinger, CCRP    843-792-7857    infingep@musc.edu   
Contact: Aparna Choudhury       choudhur@musc.edu   
Principal Investigator: Michelle Macias, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37212
Contact: Alison Vehorn    615-343-8763    alison.vehorn@Vanderbilt.edu   
Contact: Jessica Smith    615-936-3288    Jessica.smith@vanderbilt.edu   
Principal Investigator: Zachary Warren, PhD         
United States, Texas
Baylor College of Medicine/Texas Children's Hospital Recruiting
Houston, Texas, United States, 77054
Contact: Silvia Garza    832-824-3393    sxgarza3@texaschildrens.org   
Principal Investigator: Robin Kochel, PhD         
United States, Washington
Seattle Children's Recruiting
Seattle, Washington, United States, 98121
Contact: Anne Wolken    206-987-3195    anne.wolken@seattlechildrens.org   
Principal Investigator: Charles Cowan, MD         
Canada, Alberta
Glenrose Rehabilitation Hospital Recruiting
Edmonton, Alberta, Canada, T5G 0B7
Contact: Carol Wilson    780-735-8283    carol.wilson@albertahealthservices.ca   
Contact: Mayank Rehani       Mayank.Rehani@albertahealthservices.ca   
Principal Investigator: Lonnie Zwaigenbaum, MD         
Principal Investigator: Keith Goulden, MD         
Canada, Ontario
Holland Bloorview Kids Rehabilitation Hospital Recruiting
Toronto, Ontario, Canada, M4G 1R8
Contact: Dina Zaghloul    416-425-6220 ext 6602    DZaghloul@hollandbloorview.ca   
Principal Investigator: Evdokia Anagnostou, MD         
Sponsors and Collaborators
SynapDx
Investigators
Study Director: Stan Lapidus SynapDx Corp
  More Information

No publications provided

Responsible Party: SynapDx
ClinicalTrials.gov Identifier: NCT01810341     History of Changes
Other Study ID Numbers: 12002
Study First Received: March 11, 2013
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by SynapDx:
Autism
Autism Spectrum Disorders
RNA
Gene expression
Developmental Delay

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014