Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-31 @ 9:41 PM
Study NCT ID:
NCT05803005
Status:
UNKNOWN
Last Update Posted:
2023-04-07
First Post:
2023-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Some Inflammatory Markers in Autism Spectrum Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-26', 'studyFirstSubmitDate': '2023-03-26', 'studyFirstSubmitQcDate': '2023-03-26', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'inflammatory marker in autism', 'timeFrame': 'baseline', 'description': 'Evaluate some Inflammatory markers \\[IL-6, IL-8, TNF\\_alpha\\] in children with autism spectrum disorder'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'Evaluate some Inflammatory markers \\[IL-6, IL-8, TNF\\_alpha\\] in children with autism spectrum disorder', 'detailedDescription': 'several studies have suggested a correlation between ASD and abnormal immune activation (9) For instance, there is a high incidence of autistic subjects in families with other autoimmune disorders such as celiac disease and rheumatoid arthritis, suggesting a potential role for immune dysfunction in the pathophysiology of ASD High levels of IL-6 in the brain could determine alterations of synapse formation, dendritic spine development, and neuronal circuit balance \\[13\\], while in plasma they have been associated with increased stereotypical behaviors and with regressive forms of ASD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': ': 50 patients aged 3\\_18 years, equally sex distributed, who visit pediatric neurology outpatients clinic with autistic disorder at assiut university hospital will enrolled in this study and 50 controls . (According to DSM IV and ADT-R)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50 patients aged 3\\_18 years, equally sex distributed, who visit pediatric neurology outpatients clinic with autistic disorder at assiut university hospital will enrolled in this study and 50 controls . (According to DSM IV and ADT-R)\n\nExclusion Criteria:\n\n* : Asperger syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), chronic seizures and recent infection and patients with congenital anomalies'}, 'identificationModule': {'nctId': 'NCT05803005', 'briefTitle': 'Evaluation of Some Inflammatory Markers in Autism Spectrum Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Evaluation of Some Inflammatory Markers in Autism Spectrum Disorders', 'orgStudyIdInfo': {'id': 'inflammatory markers in autism'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'children with autism spectrum disorder', 'description': ': 50 patients aged 3\\_18 years, equally sex distributed, who visit pediatric neurology outpatients clinic with autistic disorder at assiut university hospital will enrolled in this study and 50 controls . (According to DSM IV and ADT-R)', 'interventionNames': ['Other: inflammatory marker in autism spectrum disorder']}], 'interventions': [{'name': 'inflammatory marker in autism spectrum disorder', 'type': 'OTHER', 'description': 'Evaluate some Inflammatory markers \\[IL-6, IL-8, TNF\\_alpha\\] in children with autism spectrum disorder', 'armGroupLabels': ['children with autism spectrum disorder']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ghada ali, graduated', 'role': 'CONTACT', 'email': 'doddamohamed96@gmail.com', 'phone': '01060012214'}, {'name': 'eman fathalla, ass.prof', 'role': 'CONTACT', 'email': 'emangad2019@med.aun.edu.eg', 'phone': '01115191158'}], 'overallOfficials': [{'name': 'gehan kamal, prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'assiut universtiy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assiut', 'investigatorFullName': 'Ghada Mohamed Ali', 'investigatorAffiliation': 'Assiut University'}}}}