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AutismNCT01541033

Biomarker of Children With Familial Autoimmune History

An observational study of Autism and Children, run by Le Bonheur Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to identify biomarkers in this subset of autism patients, design a protein based assay system for screening serum for these biomarkers and confirm that these serum antibodies are still present at one year's time. Read more about this study

Who is it for?
Ages 4 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Autism, Children
How many people
58 participants
Where
1 siteUnited States
Study dates
Nov 2009to Aug 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Children with or without autism

Who may be able to join

  • 4-17 years of age
  • male or female
  • autistic subjects must have a diagnosis of autism spectrum disorder

Who cannot join

  • Controls must have no diagnosis of autism spectrum disorder.
  • controls must be typically developing children without behavioral deviations.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • LeBonheur Children's Hospital

    Memphis, Tennessee, 38103

Other trials in United States

About this study

Official title: Biomarker Discovery In Children With Autism Plus Familial Autoimmune History

The purpose of this study is to identify biomarkers in this subset of autism patients, design a protein based assay system for screening serum for these biomarkers and confirm that these serum antibodies are still present at one year's time.

Read the detailed description

Purpose: To identify biomarkers in this subset of autism patients, design a protein based assay system for screening serum for these biomarkers and confirm that these serum antibodies are still present at one year's time.

Rationale: Autistic spectrum disorders (ASD), are an increasingly important public health concern. Estimates of prevalence of ASDs range from 1/500 to 1/150 children. Retrospective data points to immune dysfunction in some of these children and increased frequency of familial autoimmune history (FAH) has been reported in children with autism. Behavioral responses to immune modulating therapy, though in uncontrolled studies, indicate a role for autoimmunity in the pathogenesis. Preliminary prospective work has suggested an immune etiology in autism based on the high frequency of brain endothelial antibodies (BEA) in children with language regression, 2/3 of whom are on the autistic spectrum and with autism without language regression. Follow up studies in a small number of patients showed persistence of BEA after at least a year. The specific nervous system epitopes have not been identified.

Population: Approximately 15 children with clinically diagnosed autism who have first degree relatives (parents, brothers, sisters, or children) with autoimmune disorders listed on a questionnaire. Children on the autism spectrum without autoimmune history and sibling matched controls without an ASD from the Simons Foundation Autism Research Initiative (SFARI) with deidentified data in the SFARI database will be matched for age, sex and ethnicity. Plasma samples and psychometric data from the database will be provided through the database for analysis in the laboratory of Dr. Reiter.

Design: The investigators seek to identify protein biomarkers in the serum of children with carefully characterized autism who have a familial autoimmune history in first degree relatives (FAH). Cognitive defects in the mouse model of the autism spectrum disorder tuberous sclerosis complex can be ameliorated by rapamycin, an immune suppressant drug indicating the likelihood that auto-immunity plays a role in autism pathogenesis. To expedite the identification of these biomarkers the investigators will use proteomic profiling in Drosophila melanogaster. The Drosophila (fly) nervous system is highly homologous to humans at the molecular level and genetic pathways for synaptic development and function are highly conserved. Several human neurogenetic diseases including Huntington, Alzheimer, fragile X, spinal cerebellar ataxia and Parkinson disease have been successfully studied using fly genetic models. Monoclonal antibodies generated against total fly brain homogenate cross react with human neuronal tissue and are highly specific for the recognition of particular subsets of neurons in the human nervous system. Our goal is to identify biomarkers in this group of autism patients, design a protein based assay system for screening serum for these biomarkers and confirm that these serum antibodies are persistent. A similar approach was taken by Dr. Levin to identify the central nervous system (CNS) autoantigen in the human T-lymphotropic virus type 1 disease associated myelopathy/tropical spastic. Dr. Reiter's group currently uses proteomic profiling in Drosophila to identify the protein targets of the Angelman syndrome gene, UBE3A.

Conditions
Autism, Children
Keywords
autism, children
Medical subject headings
Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01541033
Study groupRoleWhat they receive
Autism with FAHChildren diagnosed with autism with first degree relatives that have autoimmune disorders.
Autism without FAHChildren diagnosed with autism without first degree relatives that have autoimmune disorders.
ControlTypically developing children

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of autistic participants with autoimmune markers

    The designed techniques will be used to first identify and then determine the frequency of autoimmune markers cross reacting with fly neuronal proteins in children with carefully characterized autism with and without a positive familial autoimmune history (FAH) in a first degree relative compared to typically developing children without FAH.

    Measured: 5 years

Secondary outcomes (1)
  1. Identification of neuronal protein autoimmunity

    Presence of autoantibodies will be correlated with presence of a positive FAH in a first degree relative. Identification of neuronal protein autoimmunity will allow further investigation of etiological factors and possible immune modulating treatment in children with autism.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2012 (estimated)
  2. Study startNov 2009
  3. Primary completionMay 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01541033
Sponsor's protocol ID
08-00206-XP
Status last verified
Aug 2016
First submitted
23 Feb 2012
Last updated
19 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Autism and Children, run by Le Bonheur Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of autistic participants with autoimmune markers (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.

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Biomarker of Children With Familial Autoimmune History | AzTrials