Nctid:
NCT06615024
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000755", "term"=>"Anemia, Sickle Cell"}, {"id"=>"D000005955", "term"=>"Glucosephosphate Dehydrogenase Deficiency"}], "ancestors"=>[{"id"=>"D000000740", "term"=>"Anemia"}, {"id"=>"D000006402", "term"=>"Hematologic Diseases"}, {"id"=>"D000000745", "term"=>"Anemia, Hemolytic, Congenital"}, {"id"=>"D000000743", "term"=>"Anemia, Hemolytic"}, {"id"=>"D000006453", "term"=>"Hemoglobinopathies"}, {"id"=>"D000030342", "term"=>"Genetic Diseases, Inborn"}, {"id"=>"D000002239", "term"=>"Carbohydrate Metabolism, Inborn Errors"}, {"id"=>"D000008661", "term"=>"Metabolism, Inborn Errors"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}], "browseLeaves"=>[{"id"=>"M4070", "name"=>"Anemia", "relevance"=>"LOW"}, {"id"=>"M4085", "name"=>"Anemia, Sickle Cell", "asFound"=>"Sickle Cell Anemia", "relevance"=>"HIGH"}, {"id"=>"M9061", "name"=>"Glucosephosphate Dehydrogenase Deficiency", "asFound"=>"G6PD Deficiency", "relevance"=>"HIGH"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"M9547", "name"=>"Hemolysis", "relevance"=>"LOW"}, {"id"=>"M4073", "name"=>"Anemia, Hemolytic", "relevance"=>"LOW"}, {"id"=>"M4075", "name"=>"Anemia, Hemolytic, Congenital", "relevance"=>"LOW"}, {"id"=>"M9539", "name"=>"Hemoglobinopathies", "relevance"=>"LOW"}, {"id"=>"M23686", "name"=>"Genetic Diseases, Inborn", "relevance"=>"LOW"}, {"id"=>"M11641", "name"=>"Metabolism, Inborn Errors", "relevance"=>"LOW"}, {"id"=>"M5498", "name"=>"Carbohydrate Metabolism, Inborn Errors", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"T5229", "name"=>"Sickle Cell Anemia", "asFound"=>"Sickle Cell Anemia", "relevance"=>"HIGH"}, {"id"=>"T2539", "name"=>"Glucose-6-phosphate Dehydrogenase Deficiency", "asFound"=>"G6PD Deficiency", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITHOUT_DNA", "description"=>"EDTA samples and serum"}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>100}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2025-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-02", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"prevelance of coexistence between sickle cell anaemia and G6PD deficiency in NEW VALLEY GOVERNORATE", "timeFrame"=>"One year", "description"=>"Evaluate the prevalence of coexistence between sickle cell anaemia and G6PD deficiency in NEW VALLEY GOVERNORATE to create data base for endemic hereditary disease"}], "secondaryOutcomes"=>[{"measure"=>"Early diagnosis to decrease incidanc of complications", "timeFrame"=>"One year", "description"=>"Early diagnosis of coexistence between sickle cell anaemia and G6PD deficiency to tell specific treatment and maintain haemoglobin level high to prevent more complications"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Sickle Cell Disease and G6PD Deficiency"]}, "descriptionModule"=>{"briefSummary"=>"G6PD deficiency may have a subtle effect on the severity of hemolysis and also worsen the degree of anaemia in SCD when the two disorders coexist. Therefore, selective decision should be taken in patients in whom the two conditions coexist in the choice of drug and in the treatment of infections.The prevalence of the G-6-PD deficiency is high in SCD patients, but does not differ from that observed among non-SCD subjects .However, the G-6-PD deficiency appears to worsen the clinical features of SCD, there were more hospitalizations, major vaso-occlusive crises among G-6-PD deficient sickle cell patients.", "detailedDescription"=>"Sickle cell disease (SCD) is not frequent in Egypt except in the Oases where the carrier rate varies from 9 to 22%. It is a hereditary blood disorder characterized by the production of abnormal hemoglobin molecules that cause red blood cells to take on a crescent or sickle shape. This haemoglobin called haemoglobin S, which causes red blood cells to become stiff and sticky, leading to various health complications as recurrent pain, fatigue, anaemia, and increased infection susceptibility.prevalence of G6PD deficiency is 4.3% with a male:female ratio of 3.2:1. Enzyme activity was significantly higher in males than females. It is located on X chromosome which leads to a lower level of reduced glutathione, an antioxidant, in red blood cells (RBCs). Most of the time, those who are affected have no symptoms. However, they should avoid specific triggers that may promote oxidative stress such as fava beans, that may fragilize RBCs and cause hemolysis. G6PD deficiency may have a subtle effect on the severity of hemolysis and also worsen the degree of anaemia in SCD when the two disorders coexist. Therefore, selective decision should be taken in patients in whom the two conditions coexist in the choice of drug and in the treatment of infections. The prevalence of the G-6-PD deficiency is high in SCD patients, but does not differ from that observed among non-SCD subjects .However, the G-6-PD deficiency appears to worsen the clinical features of SCD, there were more hospitalizations, major vaso-occlusive crises among G-6-PD deficient sickle cell patients."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"28 days", "minimumAge"=>"1 day", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"The study will be conducted on all newborn delivered in pediatric department in NEW VALLEY UNIVERSITY from jan2025 to Jan 2026", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n- All new born with good general health\n\nExclusion Criteria:\n\n* 1-new born with high reticulocytic count 2-new born with bad general health"}, "identificationModule"=>{"nctId"=>"NCT06615024", "briefTitle"=>"Screening of Coexistence Between Sickle Cell Anaemia and G6PD Deficiency", "organization"=>{"class"=>"OTHER", "fullName"=>"Assiut University"}, "officialTitle"=>"Newborn Screening of Coexistence Between Sickle Cell Anaemia and G6PD Deficiency in NEW VALLEY GOVERNORATE", "orgStudyIdInfo"=>{"id"=>"Coexistence of SCD and G6PD"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Newborns who are delivered in NEW VALLEY GOVERNORATE", "description"=>"Screening of coexistence between sickle cell anaemia and G6PD deficiency", "interventionNames"=>["Diagnostic Test: G6pd enzyme sickling test", "Diagnostic Test: G6PD enzyme and sickling test", "Diagnostic Test: G6PD enzyme and HPLC"]}], "interventions"=>[{"name"=>"G6pd enzyme sickling test", "type"=>"DIAGNOSTIC_TEST", "description"=>"Measuring the enzyme level of G6PD and presence of Hbs", "armGroupLabels"=>["Newborns who are delivered in NEW VALLEY GOVERNORATE"]}, {"name"=>"G6PD enzyme and sickling test", "type"=>"DIAGNOSTIC_TEST", "description"=>"Measuring enzyme level of G6PD and level of HbS", "armGroupLabels"=>["Newborns who are delivered in NEW VALLEY GOVERNORATE"]}, {"name"=>"G6PD enzyme and HPLC", "type"=>"DIAGNOSTIC_TEST", "description"=>"Measuring G6PD enzyme level in neonates and measuring level of HbS", "armGroupLabels"=>["Newborns who are delivered in NEW VALLEY GOVERNORATE"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Fatma Hussein Mahmoud, Assistant lecturer", "role"=>"CONTACT", "email"=>"fh449615@gmail.com", "phone"=>"01062172982", "phoneExt"=>"+2"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fatma Hussein Mahmoud", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Assistant lecturer", "investigatorFullName"=>"Fatma Hussein Mahmoud", "investigatorAffiliation"=>"Assiut University"}}}}
