[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631487":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":56,"collaborators":59,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":22,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":22,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":90,"whyStopped":22,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Medicine and Pharmacy at Ho Chi Minh City","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Children With Suspected IgE-Mediated Shrimp Allergy","EXPERIMENTAL","Children with suspected IgE-mediated shrimp allergy who undergo the study procedures, including oral food challenge, skin prick testing, and blood sampling for measurement of recombinant tropomyosin- and hemocyanin-specific IgE. Oral food challenge will be standardized using black tiger shrimp (Penaeus monodon), with additional challenge using other shrimp species when clinically indicated.",[13,14,15],"Diagnostic Test: Oral Food Challenge (OFC)","Diagnostic Test: Skin Prick Test","Diagnostic Test: Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DIAGNOSTIC_TEST","Oral Food Challenge (OFC)","Oral food challenge with shrimp performed according to the study protocol to confirm or exclude IgE-mediated shrimp allergy in children with suspected shrimp allergy. To standardize the challenge material, black tiger shrimp (Penaeus monodon) will be used in all participants. Additional oral food challenges using other shrimp species may be performed when the clinical history suggests reactions to a different shrimp species. The oral food challenge result serves as the reference standard for diagnostic evaluation in this study.",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Skin Prick Test","Skin prick testing performed as part of the diagnostic evaluation in children with suspected IgE-mediated shrimp allergy.",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Recombinant Tropomyosin- and Hemocyanin-Specific IgE Measurement","Blood testing to measure specific IgE to recombinant tropomyosin and hemocyanin as part of the diagnostic evaluation of suspected shrimp allergy.",[9],[32],{"name":33,"affiliation":5,"role":34},"Tu HK Trinh, MD, PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":22,"email":40},"Ngoc Thi Nguyen, MD","CONTACT","+84 908 876 976","ntngoc.ncs25@ump.edu.vn",[42],{"facility":43,"status":22,"city":44,"state":22,"zip":22,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Children's Hospital 1","Ho Chi Minh City","Vietnam","VN",{"type":48,"coordinates":49},"Point",[50,51],106.62965,10.82302,{"lat":51,"lon":50},[54,55],{"name":37,"role":38,"phone":39,"phoneExt":22,"email":40},{"name":37,"role":34,"phone":22,"phoneExt":22,"email":22},{"type":34,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Ngoc Thi Nguyen","Principal Investigator",[60],{"name":61,"class":6},"Children's Hospital Number 1, Ho Chi Minh City, Vietnam","100631487","recombinant-tropomyosin--and-hemocyanin-specific-ige-in-children-with-suspected-shrimp-allergy-100631487",false,"NCT07501325","Recombinant Tropomyosin- and Hemocyanin-Specific IgE in Children With Suspected Shrimp Allergy","Diagnostic Value of Recombinant Tropomyosin- and Hemocyanin-Specific IgE for the Diagnosis of IgE-Mediated Shrimp Allergy in Children in Vietnam","Inclusion Criteria:\n\n* Children aged 1 to 16 years.\n* Evaluated at the Allergy Unit of Children's Hospital 1.\n* Clinical history suggestive of IgE-mediated shrimp allergy based on EAACI 2023 criteria, including at least 1 typical allergic symptom (urticaria, angioedema, vomiting, abdominal pain, diarrhea, cough, wheezing, dyspnea, or hypotension), symptom onset within 2 hours after shrimp ingestion, and recurrence on at least 2 separate exposures.\n* Parent or legal guardian able to provide written informed consent; child assent obtained when appropriate.\n\nExclusion Criteria:\n\n* Acute illness at the time of enrollment or challenge, including acute respiratory infection, acute gastrointestinal infection, or acute asthma exacerbation.\n* Severe chronic disease, including malignancy, severe liver or kidney disease, primary immunodeficiency, or significant heart disease affecting hemodynamic status.\n* Mental or behavioral disorder that prevents completion of study procedures.\n* Use of immunosuppressive medication (oral corticosteroids, cytotoxic drugs, or biologic agents) within 4 weeks before enrollment, or intravenous immunoglobulin within the previous 3 months.\n\nExclusion Criteria:\n\n* Acute illness at the time of enrollment or challenge, including acute respiratory infection, acute gastrointestinal infection, or acute asthma exacerbation; participants may be rescheduled after recovery.\n* Severe chronic disease, including malignancy, severe liver or kidney disease, primary immunodeficiency, or significant heart disease affecting hemodynamic status.\n* Mental or behavioral disorder that prevents completion of study procedures.\n* Use of immunosuppressive medication (oral corticosteroids, cytotoxic drugs, or biologic agents) within 4 weeks before enrollment, or intravenous immunoglobulin within the previous 3 months.","ALL","1 Year","16 Years",{"count":73,"type":74},129,"ESTIMATED","INTERVENTIONAL",[77],"NA","This study will evaluate whether blood tests that measure IgE antibodies to two shrimp proteins, tropomyosin and hemocyanin, can help diagnose shrimp allergy in children. Children with suspected IgE-mediated shrimp allergy will undergo oral food challenge, skin prick testing, and blood sampling. Oral food challenge results will be used as the reference standard to determine whether these tests can accurately identify true shrimp allergy and help improve diagnosis in clinical practice.",[80,81],"Food Hypersensitivity","Shellfish Allergy",[83,24,84,85,86,87,81,88,80,89],"Oral Food Challenge","Tropomyosin","Hemocyanin","Specific IgE","Recombinant Allergen","Children","Shrimp Allergy","NOT_YET_RECRUITING","2026-03-31",{"date":93,"type":94},"2026-04-06","ACTUAL",{"date":96,"type":74},"2026-04",{"date":98,"type":74},"2028-04",{"name":5,"class":6},1]