Extracellular Signal-Related Kinase Biomarker Development in Autism

NCT01850459 | Completed

• 1 other identifier: CIN001- ERK in Autism
• Study Type: observational
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to establish a way to help the development of targeted treatments in autism spectrum disorders. This may also help in early diagnosis of autism and may possibly predict severity. The study will compare subject's ERK (extracellular signal-related kinase) signaling to age- and gender-matched neurotypical controls and Intelligence quotient (IQ)-matched developmental disabilities.

Conditions

Autism Spectrum Disorders

Outcome Measures

Primary Outcomes (1)

• ERK activation

  Up to three years

Study Arms (4)

Autism Spectrum Disorder group

Diagnosis of autistic disorder as confirmed by a clinical interview, utilizing the DSM-V

IQ-Matched Control Subjects

Age-Matched Neurotypical Controls

Shipped Biomarker Control Group Subjects

These subjects provide a blood sample only that serves as a shipping control that is shipped along with all blood samples from Autistic Disorder Subjects, IQ-Matched Control Subjects or Age-Matched Neurotypical Control Subjects. For these shipping control samples, blood samples will also be drawn from the subjects.

Eligibility Criteria

• Age: 3 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The subjects with autism will be recruited through the clinic population at Cincinnati Children's Hospital Medical Center. Recruitment of subjects will be conducted by notifying via, IRB approved electronic and paper ads, individuals with autistic disorder, their families, treating clinicians and agencies throughout the referral base of CCHMC and those within our existing clinical services, residential facilities, schools and group homes for the developmentally disabled.

You may qualify if:

• Diagnosis of autistic disorder as confirmed by a clinical interview, utilizing the DSM-V
• Age 3-25 years
• Stable dosing of psychotropic drugs for 5 half-lives or greater

You may not qualify if:

• Diagnosis of schizophrenia, another psychotic disorder, bipolar disorder, or alcohol or other substance abuse based on DSM-V criteria
• Use of lithium, riluzole or other known modulators of ERK activation
• IQ-Matched Control Subjects: Those subjects who are included in the study based on having an IQ and age that matches the IQ and age of an Autistic Disorder Subject who has an IQ less than 70. All IQ-Matched Control Subjects will then also have an IQ less than 70. IQ-Matched Control Subjects participate in a Screen/Baseline visit only.
• Age-Matched Neurotypical Control Subjects: Those subjects who are included in the study based on having an age matched to the age of an Autistic Disorder Subject and a history of normal development. Age-Matched Neurotypical Subjects participate in a Screen/Baseline visit only.
• Shipped Biomarker Control Group Subjects: For these shipping control samples, blood samples will also be drawn from adult parent/guardians of participating subjects.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

For the ERK activation assay, about 5 mL of whole blood is layered onto 3 mL Histopaque in a 15 mL centrifuge tube, and centrifuged. The lymphocyte-containing cell layer is removed and transferred for washing. After a second wash, cells are resuspended and rested. They are then stimulated by addition of phorbol myristate acetate and sample aliquots are removed at short intervals, fixed and permeabilized. Fixed, permeabilized cells are stained by addition of Alexafluor488-labeled monoclonal antibody to phospho-ERK in the dark for 30 min. Washed, resuspended cells are analyzed in a Coulter flow cytometer.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Craig A. Erickson, M.D.

  Children's Hospital Medical Center, Cincinnati

  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: May 7, 2013
• First Posted: May 9, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

US (1)