[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515425":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":10,"centralContacts":26,"locations":36,"responsibleParty":55,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":10,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"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,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Regenerative Medicine Center","RECRUITING","Tianjin","Tianjin Municipality","China","CN",{"type":45,"coordinates":46},"Point",[47,48],117.17667,39.14222,{"lat":48,"lon":47},[51,53],{"name":28,"role":29,"phone":52,"phoneExt":10,"email":31},"(86)2223900913",{"name":33,"role":29,"phone":54,"phoneExt":10,"email":35},"(86)13752253515",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Jun Shi","Director, Regenerative Medicine Clinic Center","100515425","growth-and-development-related-outcomes-in-children-with-transfusion-dependent-beta-thalassemia-after-gene-therapy-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":71,"type":72},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.",[76,77],"Transfusion-dependent Beta-Thalassemia","Gene Therapy",[76,79,80,81],"gene therapy","cohort study","case-control","2023-08-06",{"date":84,"type":85},"2023-08-14","ACTUAL",{"date":87,"type":85},"2023-06-05",{"date":89,"type":72},"2029-12-31",{"name":5,"class":6},1]