protocolSection identificationModule nctId: NCT06339177, orgStudyIdInfo id: 10001899, secondaryIdInfos id: 001899-I, briefTitle: Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2030-10-01, completionDateStruct date: 2031-04-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute of Allergy and Infectious Diseases (NIAID), class: NIH, descriptionModule briefSummary: Background:Hemophagocytic lymphohistiocytosis (HLH) is a disease caused by disrupted immune function. People with HLH are prone to fevers and illnesses, which can be fatal. Some people develop a genetic form of this disease (pHLH), but researchers do not understand why some other people develop a nongenetic form (sHLH). They also do not have good ways to diagnose and treat sHLH.Objective:To learn about sHLH and why some people get it and others do not.Eligibility:Adults aged 18 years and older with sHLH.Design:Participants will be admitted to the study based on a review of their medical records. Those who join will have at least 3 clinical evaluations over 9 to 12 months. These may occur during an inpatient hospitalization if they require medical care or in the outpatient clinic.Participants will also have a physical exam at each visit. Up to half a cup of blood will be drawn at each visit. Participants may also have their blood drawn by their own doctors, who will send the samples to the researchers. Researchers may also contact these participants by telephone or video calls.The blood will be used for clinical tests as well as research. No new treatments will be administered as part of this study; however, standard medications and treatments may be recommended.Participants may opt to continue their visits once a year for 3 more years. Participants may also opt for an extra clinial evaluation 1 week after starting a new treatment...., conditionsModule conditions: Lymphohistiocytosis, Hemophagocytic, conditions: Secondary Hemophagocytic Lymphohistiocytosis, conditions: Macrophage Activation Syndrome, conditions: Hyperinflammatory Syndromes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Identify immunologic mechanisms involved in the pathogenesis of sHLH from a variety of predisposing conditions., secondaryOutcomes measure: Prospectively define acute and longitudinal clinical profiles that predict key clinical outcomes., secondaryOutcomes measure: Compare clinical and immune profiles between the classically defined HLH subgroups., secondaryOutcomes measure: Improve the understanding of the pathogenesis of sHLH., secondaryOutcomes measure: Characterize risk factors to identify populations at risk for developing sHLH., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institutes of Health Clinical Center, status: RECRUITING, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: NIH Clinical Center Office of Patient Recruitment (OPR), role: CONTACT, phone: 800-411-1222, phoneExt: TTY dial 711, email: ccopr@nih.gov, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False