Ignite Creation Date:
2024-05-06 @ 2:57 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02168868
Status:
RECRUITING
Last Update Posted:
2023-02-27
First Post:
2014-06-19
Brief Title:
Immune Tests in Blood Samples From Children With ASD
Sponsor:
Benjamin Gesundheit
Organization:
Cell El Ltd
Study Overview
Official Title:
In Vitro Immune Tests in Blood Samples From Children With ASD
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eliminate the need for trained staff and enable early intervention Such a test would not only conserve money and time but would also provide clues to ASD pathogenesis
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 involving the following cohorts
1 young children diagnosed with ASD
2 young children diagnosed with ASD and scheduled to undergo stem cell transplantation therapy SCT
3 age- and sex-matched typically developing children
4 high-risk infants 10-18 months with at least one sibling with diagnosed ASD
5 mothers of these high-risk infants
Parents will be asked to complete several questionnaires relating to demographic and anamnestic details and to the childs development
A single blood draw will be performed in the clinic and single stool and urine samples will be collected at home For children scheduled to undergo SCT the blood stool and urine samples must be collected before therapy For participating mothers only a single blood sample will be collected no stools or urine samples
Parents of high-risk infants will be contacted by phone or email when the child reaches diagnosable age 35 years and again at the age of 6 years to obtain an update on the childs ASD status If the child has been diagnosed with ASD an additional blood and stool sample may be collected
Children who underwent SCT will be contacted 21 months and 61 months after the first treatment session for collection of additional blood samples Stool and urine samples will be collected at the 61 month post-treatment visit as well Should the child undergo additional SCT within two years of the first treatment additional blood stool and urine samples may be collected At each subsequent visit a parentlegal guardian will be asked to complete several short questionnaires
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
The study will follow a case-control design involving the following cohorts
1 young children diagnosed with ASD
2 young children diagnosed with ASD and scheduled to undergo stem cell transplantation therapy SCT
3 age- and sex-matched typically developing children
4 high-risk infants 10-18 months with at least one sibling with diagnosed ASD
5 mothers of these high-risk infants
Parents will be asked to complete several questionnaires relating to demographic and anamnestic details and to the childs development
A single blood draw will be performed in the clinic and single stool and urine samples will be collected at home For children scheduled to undergo SCT the blood stool and urine samples must be collected before therapy For participating mothers only a single blood sample will be collected no stools or urine samples
Parents of high-risk infants will be contacted by phone or email when the child reaches diagnosable age 35 years and again at the age of 6 years to obtain an update on the childs ASD status If the child has been diagnosed with ASD an additional blood and stool sample may be collected
Children who underwent SCT will be contacted 21 months and 61 months after the first treatment session for collection of additional blood samples Stool and urine samples will be collected at the 61 month post-treatment visit as well Should the child undergo additional SCT within two years of the first treatment additional blood stool and urine samples may be collected At each subsequent visit a parentlegal guardian will be asked to complete several short questionnaires
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None