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Immune Tests in Blood Samples From Children With ASD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168868
Recruitment Status : Unknown
Verified December 2014 by Cell El Ltd.
Recruitment status was:  Recruiting
First Posted : June 20, 2014
Last Update Posted : December 25, 2014
Sponsor:
Collaborators:
Assaf-Harofeh Medical Center
Shaare Zedek Medical Center
Information provided by (Responsible Party):
Cell El Ltd

Brief Summary:
The purpose of this study is to analyze the immunological profile in blood of children with ASD.

Condition or disease
Autistic Disorder

Detailed Description:

There is accumulating evidence that at least a subset of children diagnosed with ASD also have aberrant immune functions. This study will attempt to identify more specifically the nature of the potential immune abnormalities in children.

The study will follow a case-control design. Only one blood drawing will be performed upon meeting the inclusion criteria and completing a questionnaire that includes detailed information regarding family history of immune aberrations. Five ml of venous blood will be drawn from all subjects (ASD and controls) and shall be separated into 2 vials:

  • 0.5 ml: for Complete Blood Count
  • 4.5 ml for serum separation. The serum will be aliquoted (0.5 ml vials) and frozen at -80º centigrade and sent to laboratory for detailed immune analysis. One aliquot will be sent for analysis. The others will be kept for further testing (±backup).

Adverse events to blood drawing will be reported to the Data Coordinating Center using the appropriate Case Report Form (CRF).

In cases of adverse effects (AE) related to the drawing of blood or performance of examination of patients in the course of standard examination procedures, the investigating team will proceed in accordance with local guidelines (to be inserted by the PI), reporting the incidents which occurred during the course of a clinical trial.

Clinical data will be collected by the investigator, or a person appointed and appropriately trained by the investigator, and shall be entered into standardized CRFs and shared online with the sponsor. Source data will be retained for all data entered in the CRFs. Progress reports and the Final Report at the conclusion of the trial will be submitted to the regulatory authority and the Ethics Committee, as required.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 450 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: In Vitro Immune Tests in Blood Samples From Children With ASD
Study Start Date : May 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Group/Cohort
Control Group of Children
Control Group of Children
Children-Autism Spectrum Disorder
Children-Autism Spectrum Disorder



Primary Outcome Measures :
  1. Evidence of Immunological Aberrations Confirmed by Immunological Assays [ Time Frame: within three months of blood drawing ]

Biospecimen Retention:   Samples Without DNA
serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children diagnosed with Autism Spectrum Disorder according to DSM-4 from hospital or kupat cholim (local HMO's)
Criteria

Inclusion Criteria:

  • Male and female children
  • age 2-12
  • Diagnosed autism spectrum disorder (ASD) according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV (299.00) or DSM-V (299.00).
  • Informed consent signed by the parents

Exclusion Criteria:

  • All children that have been treated with systemic steroids or have undergone immune suppression treatment over the last 6 months.
  • All children diagnosed with severe infectious diseases or sepsis over the last 6 months.
  • All children diagnosed with mild infectious diseases (including common cold, ear infection, etc.) over the last month
  • Children with ASD treated for a severe convulsive disorder.
  • Children with hematological or malignant disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168868


Contacts
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Contact: Benjamin Gesundheit, M.D. 011972506558638 b.gesund@gmail.com
Contact: Josh Rosenzweig, M.D. 011972526148181 joshpros@gmail.com

Locations
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Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Contact: Avraham Steinberg, MD       avraham@steinberg.onmicrosoft.com   
Principal Investigator: Avraham Steinberg, MD         
Assaf Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Ditza Zachor, MD       dzachor@asaf.health.gov.il   
Contact: Nava Weil    011972546371636    navaweill@gmail.com   
Principal Investigator: Ditza Zachor, MD         
Sponsors and Collaborators
Cell El Ltd
Assaf-Harofeh Medical Center
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Benjamin Gesundheit, M.D. Cell El Ltd
Principal Investigator: David Naor, PhD Lautenberg Center for General and Tumor Immunology, The Hebrew University Hadassah Medical School
Principal Investigator: Michal Melamed, PhD Cell El Ltd
Principal Investigator: Josh Rosenzweig, MD Cell El Ltd
Additional Information:

Publications:
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Responsible Party: Cell El Ltd
ClinicalTrials.gov Identifier: NCT02168868    
Other Study ID Numbers: CellEL-920130030
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: December 25, 2014
Last Verified: December 2014
Keywords provided by Cell El Ltd:
Autoimmune Diseases
Child Development Disorders, Pervasive
Inflammation
Risk Factors
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders