Immune Tests in Blood Samples From Children With ASD
Study Details
Study Description
Brief Summary
Behavioral testing is the gold standard for diagnosing ASD. These tests, including ADOS and ADI-R are subjective, require trained staff to administer, are time-consuming, and can only be administered at a later age. Blood-, urine- or stool-based diagnostic biomarker test for ASD would enable objective early diagnosis, potentially even before clinical symptoms are present, hence early behavioral intervention, and potentially eliminating the need for trained staff. Ideally, such a test would not only conserve money and time but would also provide clues to ASD pathogenesis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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0.5 ml: for Complete Blood Count
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Control Group of Children 2-12 years old age & sex-matched controls (age-matched within ±12 months) - typically developing (TD) children and their mothers. |
Diagnostic Test: Blood Draw
For children who had recently undergone ASD-directed treatment (≤60 days), a single blood sample (5 mL) will be collected at three independent visits, conducted at 2-month intervals.
For untreated children, a single venous blood sample (5 mL) will be drawn from all subjects (ASD and control children).
For mothers, a single venous blood sample (5 mL) will be drawn.
Other Names:
Diagnostic Test: Stool Sample Collection
Subjects (ASD and TDs as control children) will be provided a dry, plastic, screw-top specimen container and will be asked to collect a stool sample at home.
Other Names:
Diagnostic Test: Urine Sample Collection
Subjects (ASD and TDs as control children) will be provided a dry, plastic, screw-top specimen container and will be asked to collect a urine sample at home.
Other Names:
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| Children-Autism Spectrum Disorder 2-12 years old children diagnosed with ASD according to DSM-IV (299.00) or DSM-V (299.00), and their mothers. 4:1 case:control ratio. |
Diagnostic Test: Blood Draw
For children who had recently undergone ASD-directed treatment (≤60 days), a single blood sample (5 mL) will be collected at three independent visits, conducted at 2-month intervals.
For untreated children, a single venous blood sample (5 mL) will be drawn from all subjects (ASD and control children).
For mothers, a single venous blood sample (5 mL) will be drawn.
Other Names:
Diagnostic Test: Stool Sample Collection
Subjects (ASD and TDs as control children) will be provided a dry, plastic, screw-top specimen container and will be asked to collect a stool sample at home.
Other Names:
Diagnostic Test: Urine Sample Collection
Subjects (ASD and TDs as control children) will be provided a dry, plastic, screw-top specimen container and will be asked to collect a urine sample at home.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Identification of ASD-specific immunological biomarkers and/or signatures in blood samples collected from ASD children. [through study completion, an average of 1 year]
Finding immunological biomarkers that are ASD specific.
Secondary Outcome Measures
- Correlative assessment of ASD severity vs. biomarker levels [through study completion, an average of 1 year]
- Correlative assessment of biomarker levels and subject age [through study completion, an average of 1 year]
- Correlative assessment of biomarker levels and subject gender [through study completion, an average of 1 year]
Other Outcome Measures
- Identification of ASD-specific immunological signatures and/or biomarkers in stool samples [through study completion, an average of 1 year]
- • Identification of ASD-specific immunological signatures and/or biomarkers in blood samples collected from children with ASD and a seizure disorder [through study completion, an average of 1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female children
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Age 2-12
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Autism spectrum disorder (ASD) according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV (299.00) or DSM-V (299.00)
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Informed consent signed by the parents
Exclusion Criteria:
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Child and/or mother that have been treated with systemic steroids or have undergone immune suppression treatment within the last 6 months
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Child and/or mother diagnosed with severe infectious diseases or sepsis over the last 6 months
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Child and/or mother diagnosed with mild infectious diseases (including common cold, ear infection, etc.) over the last month
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Child and/or mother with hematological or malignant disorder
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Child who underwent ASD-directed treatment >60 days prior to enrolment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shaare Zedek Medical Center | Jerusalem | Israel | 91031 |
Sponsors and Collaborators
- Cell El Ltd
- Assaf-Harofeh Medical Center
- Shaare Zedek Medical Center
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- CellEL-920130030