Nctid:
NCT06614998
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000051359", "term"=>"Lymphohistiocytosis, Hemophagocytic"}], "ancestors"=>[{"id"=>"D000015616", "term"=>"Histiocytosis, Non-Langerhans-Cell"}, {"id"=>"D000015614", "term"=>"Histiocytosis"}, {"id"=>"D000008206", "term"=>"Lymphatic Diseases"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M26695", "name"=>"Lymphohistiocytosis, Hemophagocytic", "asFound"=>"Hemophagocytic Syndrome", "relevance"=>"HIGH"}, {"id"=>"M18216", "name"=>"Histiocytosis", "relevance"=>"LOW"}, {"id"=>"M18218", "name"=>"Histiocytosis, Non-Langerhans-Cell", "relevance"=>"LOW"}, {"id"=>"M11203", "name"=>"Lymphatic Diseases", "relevance"=>"LOW"}, {"id"=>"T4155", "name"=>"Non-Langerhans-Cell Histiocytosis", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M8191", "name"=>"Etoposide", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M341643", "name"=>"Etoposide phosphate", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_ONLY"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>80}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-05-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-05-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-27", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-05-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The suspected patient was diagnosed with hemophagocytic syndrome after complete NK cell activity, triglyceride tests, etc.", "timeFrame"=>"Time forecasting:2 years"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["hemophagocytic syndrome screening system"], "conditions"=>["Hemophagocytic Syndrome"]}, "descriptionModule"=>{"briefSummary"=>"Our three-step screening system uses commonly used clinical and laboratory parameters to effectively identify patients who may be at high risk of HLH, conduct etiology screening early for patients who meet the diagnostic criteria for HLH, and guide standardized treatment. Therefore, this study proposes to establish a highly accurate and convenient hemophagocytic early warning system to improve the early diagnosis of patients with hemophagocytic syndrome and identify suspected HLH patients early. Etiology screening is performed on patients who meet the diagnostic criteria for HLH, high-risk predisposing factors are identified, and precise treatment is guided, thereby improving the success rate of patient treatment and improving the quality of life."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"A three-step screening process identified 80 people with suspected hemophagocytic syndrome", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nSubjects must meet all of the following criteria:\n\n1. Patients who meet the first step screening + have ≥ 3 abnormal screening indicators in the second step\n2. Patients who meet the first step screening + have 2 abnormal screening indicators in the second step + patients with high-risk factors for HLH, such as history of lymphoma, EBV infection, autoimmune diseases, etc\n\nExclusion Criteria:\n\nExclusion Criteria Subjects who meet one of the following criteria will not be enrolled: 1. Patients with liver cirrhosis, liver cancer, and hepatic encephalopathy 2. Patients with trauma, hepatosplenic rupture and other organ hemorrhage 3. Patients with severe disease such as shock, sepsis, and multiple organ failure 4. Patients with DIC 5. Patients with long-term anemia 6. Patients with acute promyelocytic leukemia 7. Patients with idiopathic deafness 8. Patients who have taken hormones/immunosuppressants 72 hours before admission 9. Hereditary fibrinogen deficiency"}, "identificationModule"=>{"nctId"=>"NCT06614998", "briefTitle"=>"Establishment of an Early Warning Screening System for Hemophagocytic Lymphohistiocytosis a Multi-center, Prospective Study", "organization"=>{"class"=>"OTHER", "fullName"=>"The Affiliated Hospital of Xuzhou Medical University"}, "officialTitle"=>"Establishment of an Early Warning Screening System for Hemophagocytic Lymphohistiocytosis: a Multi-center, Prospective Study", "orgStudyIdInfo"=>{"id"=>"XYFY2024-KL100-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Screening patients with suspected hemophagocytic syndrome", "description"=>"Preliminary screening of patients with elevated ferritin and low fibrinogen, and then continue to improve triglycerides, abdominal color ultrasound and other examinations to further clarify, for some very suspicious patients, timely improve genes, NK cell activity and other tests, as soon as possible to determine whether they are patients with hemophagocytic syndrome", "interventionNames"=>["Drug: Patients diagnosed with HLH-94 should be treated as soon as possible"]}], "interventions"=>[{"name"=>"Patients diagnosed with HLH-94 should be treated as soon as possible", "type"=>"DRUG", "description"=>"For some highly suspicious patients, after diagnosis, according to the patient's etiology, the treatment plan should be determined as soon as possible, such as lymphoma-related patients treated with hormones combined with etoposide, which can greatly improve the prognosis of patients", "armGroupLabels"=>["Screening patients with suspected hemophagocytic syndrome"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"221006", "city"=>"Xuzhou", "state"=>"Jiangsu", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Wei Sang, Docter", "role"=>"CONTACT", "email"=>"sw1981726@126.com", "phone"=>"13645207648"}], "facility"=>"Affilitated Hospital of Xuzhou Medical University", "geoPoint"=>{"lat"=>34.18045, "lon"=>117.15707}}], "centralContacts"=>[{"name"=>"Wei Sang, Doctor", "role"=>"CONTACT", "email"=>"sw1981726@126.com", "phone"=>"13645207648"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"The Affiliated Hospital of Xuzhou Medical University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
