[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515425":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":10,"centralContacts":26,"locations":36,"responsibleParty":54,"collaborators":10,"id":58,"slug":10,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":10,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Gene therapy group",null,"TDT Children who have received gene therapy between 3\\~14 years old.",[13],"Genetic: Gene therapy",{"label":15,"type":10,"description":16,"interventionNames":10},"Supportive therapy group","TDT Children who received lifelong treatment with blood transfusions and iron chelation. They were selected based on the age and sex of the gene therapy group.",{"label":18,"type":10,"description":19,"interventionNames":10},"Healthy children group","Healthy children were selected based on the age and sex of the gene therapy group.",[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"GENETIC","Gene therapy","Autologous edited hematopoietic stem cell transplantation",[9],[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Jun Shi, PhD","CONTACT","2223900913","shijun@ihcams.ac.cn",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},"Jingyu Zhao, MPH","13752253515","zhaojingyu@ihcams.ac.cn",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":10,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Regenerative Medicine Center","RECRUITING","Tianjin","Tianjin Municipality","China",{"type":44,"coordinates":45},"Point",[46,47],117.17667,39.14222,{"lat":47,"lon":46},[50,52],{"name":28,"role":29,"phone":51,"phoneExt":10,"email":31},"(86)2223900913",{"name":33,"role":29,"phone":53,"phoneExt":10,"email":35},"(86)13752253515",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Jun Shi","Director, Regenerative Medicine Clinic Center","100515425",false,"NCT05991336","Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy","Growth and Development, Health-related Quality of Life of Children With Transfusion-dependent Beta-thalassemia After Gene Therapy","Inclusion Criteria:\n\nGene therapy group-inclusion\n\n* Male or female age of 3-14 years\n* TDT Children who have received gene therapy.\n* Subjects who are willing and able to provide written informed consent.\n\nSupportive therapy group-inclusion\n\n* Gender same as the matched case\n* Age similar to the matched case\n* Children with β-TDT\n* No history of gene therapy or allogeneic hematopoietic stem cell transplantation\n* Subjects who are willing and able to provide written informed consent.\n\nHealthy children group-inclusion\n\n* Gender same as the matched case\n* Age similar to the matched case\n* Subjects who are willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of compound α-thalassemia\n* Uncontrolled systemic fungal, bacterial, or viral infection\n* History of malignant solid tumors, myeloproliferative or immunodeficiency diseases\n* Diagnosed with mental illness\n* Patients considered to be ineligible for the study by the investigator for reasons other than the above\n\nDiscontinuation of Study :\n\n* Subjects who are unwilling or unable to continue participating in the study (withdrawal of informed consent) may withdraw from the study\n* Subjects who received gene therapy or allogeneic hematopoietic stem cell transplantation during the study\n* The subject is seriously non-compliant with the study requirements, such as missing 2 consecutive visits\n* Subject lost to follow-up",true,"ALL","3 Years","14 Years",{"count":69,"type":70},100,"ESTIMATED","OBSERVATIONAL","The investigate will conduct a cohort study to compare the growth and development, metabolism, lifestyle behavior, and health-related quality of life among three groups: children with transfusion-dependent β-thalassemia (TDT) who have received gene therapy, TDT children with lifelong supportive therapy and healthy children.",[74,75],"Transfusion-dependent Beta-Thalassemia","Gene Therapy",[74,77,78,79],"gene therapy","cohort study","case-control","2023-08-06",{"date":82,"type":83},"2023-08-14","ACTUAL",{"date":85,"type":83},"2023-06-05",{"date":87,"type":70},"2029-12-31",{"name":5,"class":6},1]