[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625846":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":47,"studyPopulation":40,"armGroups":48,"interventions":55,"overallOfficials":40,"centralContacts":61,"locations":70,"responsibleParty":89,"collaborators":40,"id":91,"slug":40,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":40,"studyType":104,"phases":105,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":73,"whyStopped":40,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":40,"otherOutcomes":40},[9,13,16,19,22,25,28,31,34,37],{"measure":10,"description":11,"timeFrame":12},"Measurement of severity of ASD core symptoms with ADOS2","Outcome unity of measure: Calibrated Severity Scores - Measure range: 1-10","1 year",{"measure":14,"description":15,"timeFrame":12},"Measurement of severity of ASD core symptoms with SRS 2","Outcome unity of measure: T-score - Measure range: 30-90",{"measure":17,"description":18,"timeFrame":12},"Measurement of developmental abilities with Griffiths III scales","Outcome unity of measure: GQ - Measure range: \\\u003C20-150",{"measure":20,"description":21,"timeFrame":12},"Measurement of cognitive abilities with Wechsler scales","Outcome unity of measure: IQ - Measure range: \\\u003C20-160",{"measure":23,"description":24,"timeFrame":12},"Measurement of cognitive abilities with Leiter 3 scales","Outcome unity of measure: IQ - Measure range: 40-160",{"measure":26,"description":27,"timeFrame":12},"Quantification of emotional and behavioral problems with CBCL","Outcome unity of measure: Raw score - Measure range: 0-200 for children \\\u003C6 years old \u002F and 0-226 for children 6-18 years old",{"measure":29,"description":30,"timeFrame":12},"Verification on iPSs of presence\u002Fabsence of expression of stem cell genes and genes from the three embryonic layers","Outcome unity of measure: Gene expression - Measure range: yes\u002Fno",{"measure":32,"description":33,"timeFrame":12},"Percentage of hiNSCs differentiating into astrocytes, oligodendrocytes, and neurons","Outcome unity of measure: % cells differentiated\u002Ftot numeber of cells - Measure range: 0-100%",{"measure":35,"description":36,"timeFrame":12},"Measurement of length of neurite growth in hiNSCs","Outcome unity of measure: µm - Measure range 0-500 µm",{"measure":38,"description":39,"timeFrame":12},"Measurement of concentration of distinct lipid molecular species in ASD derived cells and control derived cells in order to assess the differences in lipidomic profiles","Outcome unity of measure: µmol\u002FL - Measure range: 0.001 µmol\u002FL - \\>10,000 µmol\u002FL",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":46,"maskingDescription":40,"whoMasked":40},"NONE","ASD is a neurodevelopmental disorder affecting about 1 in 36 children and with a frequency increasing over time, thus delineating a significant social and public health problem that needs to be faced, as well as an important field of study and research.\n\nThis project starts from the idea that complex diseases such as ASD must be tackled with a multidisciplinary approach.\n\nThe investigators are collecting a large number of somatic cells from ASD patients who have been highly characterized and stratified in subgroups from a clinical, genetic, neurological and neuropsychological point and reprogramming these cells into induced pluripotent stem cells from which the cells of three embryonic germ layers originate.\n\nCombining the expertise of the two Units, the project will have two short-term results:\n\n1. a large collection of cell models from highly characterized ASD patients that can be shared with scientific community to speed up the understanding of the causes of the disease\n2. the knowledge of pathological pathways of cells belonging to well characterized patients: omic analyses will be correlated to clinical\u002Fgenetic data to understand if a specific subgroup has specific omic profile or the same profile is common to all ASD subgroups, if a specific clinical feature or genetic polymorphism is correlated with omic data.",[49],{"label":50,"type":51,"description":52,"interventionNames":53},"Single arm study","EXPERIMENTAL","the arm is constituted by 100 pediatric patients (aged -15) with ASD diagnosis",[54],"Biological: Blood sample collection for ASD cells model production and Omic studies",[56],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":40},"BIOLOGICAL","Blood sample collection for ASD cells model production and Omic studies","The blood sample collection performed in the study is for research purposes only and therefore not collected for clinical purposes. The patient cohort is extensively studied and well stratified, so cell models production and subsequent Omic analyses could be cross-referenced with detailed phenotype data.",[50],[62,67],{"name":63,"role":64,"phone":65,"phoneExt":40,"email":66},"Stefano D'Arrigo, M.D.","CONTACT","02.2394.2210","stefano.darrigo@istituto-besta.it",{"name":68,"role":64,"phone":40,"phoneExt":40,"email":69},"Sara Bulgheroni","sara.bulgheroni@istituto-besta.it",[71],{"facility":72,"status":73,"city":74,"state":40,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Foundation IRCCS Carlo Besta Neurological Institute","RECRUITING","Milan","20133","Italy","IT",{"type":79,"coordinates":80},"Point",[81,82],9.18951,45.46427,{"lat":82,"lon":81},[85],{"name":86,"role":64,"phone":87,"phoneExt":88,"email":66},"Stefano D'arrigo, MD","02.2394.","2210",{"type":90,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100625846",false,"NCT07427940","Omic Profile in Autism Spectrum Disorder: From Cellular Level Towards Future Treatments","Aut_Omic","Inclusion Criteria:\n\n* Defined ASD diagnosis according to DSM-5 criteria\n* Age 3-15 years\n* Informed consent signed by the guardians\u002Flegal representatives.\n\nExclusion Criteria:\n\n* Exclusion criteria for Group 1 will be: having a defined genetic diagnosis or an overall clinical presentation strongly suggestive for a syndromic condition. For this definition we will apply the criteria ASD associated with at least one of the following: \\>=3 facial anomalies, \\>=1 major\u002F\\>=2 minor malformation (following EUROCAT classification), clinical issue affecting \\>=2 systems. Children showing such phenotypes but having no current genetic diagnosis could not be included in the study. Patients with a syndromic presentation and confirmed genetic diagnosis will be included in the Syndromic Group 2.\n* No standardized test to establish diagnosis\n* Parents refusing to complete the consent form\n* Impossible blood sample collection.",true,"ALL","3 Years","15 Years",{"count":102,"type":103},100,"ESTIMATED","INTERVENTIONAL",[42],"This is an interventional non pharmacological study in pediatric patientis affected by Autism Spectrum Disorder. It ams to create a collection of iPSCs and hiNSCs derived from deeply characterized ASD patients, to omics-characterize the cells, and to study the behavioral pattern of microglia-like cells in the onset of ASD.",[108],"Autism Spectrum Disorder",[108,110,111,112,113],"Neurodevelopmental disorders","iPSCs","hiNSCs","Microglia","2026-02-17",{"date":116,"type":117},"2026-02-23","ACTUAL",{"date":119,"type":117},"2024-08-31",{"date":121,"type":103},"2026-08-31",{"name":5,"class":6},1]