[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653938":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":46,"studyPopulation":39,"armGroups":47,"interventions":56,"overallOfficials":70,"centralContacts":75,"locations":85,"responsibleParty":103,"collaborators":106,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":39,"eligibilityCriteria":117,"healthyVolunteers":114,"sex":118,"minAge":119,"maxAge":39,"enrollmentInfo":120,"targetDuration":39,"studyType":123,"phases":124,"briefSummary":125,"conditions":126,"keywords":133,"overallStatus":88,"whyStopped":39,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Indiana University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Number of patients with diagnoses","Proportion of patients diagnosed with each of the following by histopathology and immunohistochemistry: tuberculosis, lymphoma, MCD, other diagnosis, or non-diagnostic.","Enrollment",[14,17,19,21,23,25,27,30,33,36],{"measure":15,"description":16,"timeFrame":12},"Baseline clinical and laboratory characteristics","HIV viral load (the number of copies of HIV RNA per milliliter of blood plasma, copies\u002FmL)",{"measure":15,"description":18,"timeFrame":12},"CD4 count",{"measure":15,"description":20,"timeFrame":12},"complete blood count",{"measure":15,"description":22,"timeFrame":12},"creatinine and liver panel",{"measure":15,"description":24,"timeFrame":12},"plasma storage",{"measure":15,"description":26,"timeFrame":12},"buffy coat storage",{"measure":28,"description":29,"timeFrame":12},"Diagnostic performance of KSHV DNA quantification using TINY","Using lymph node fine needle aspiration (FNA) and tissue biopsy samples using TINY for the diagnosis of KSHV",{"measure":31,"description":32,"timeFrame":12},"Diagnostic performance of EBV DNA quantification using TINY","Using lymph node fine needle aspiration (FNA) and tissue biopsy using TINY for the diagnosis of EBV",{"measure":34,"description":35,"timeFrame":12},"Performance of KSHV DNA quantification using TINY","Using a peripheral blood sample using TINY for the diagnosis of KSHV",{"measure":37,"description":38,"timeFrame":12},"Performance of EBV DNA quantification using TINY","Using peripheral blood sample using TINY for the diagnosis of EBV",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE","To address the need for new approaches to diagnose lymphoma and multicentric Castleman disease (MCD), investigators have developed an assay based on nucleic acid measurement that has the potential to be delivered at the point of clinical care. It has demonstrated the ability to detect Epstein-Barr virus (EBV) from fine needle aspirations (FNA) and from tumor cells using the Tiny Isothermal Nucleic acid Amplification System (TINY) device, employing primers for EBV-encoded small RNAs (EBER). The method takes advantage of the now well-established finding that Kaposi sarcoma herpesvirus (KSHV) is nearly entirely sensitive (though not specific) for the diagnosis of MCD.",[48],{"label":49,"type":50,"description":51,"interventionNames":52},"HIV-infected patients with unexplained lymphadenopathy","EXPERIMENTAL","HIV-infected patients in routine clinical care with unexplained lymphadenopathy",[53,54,55],"Procedure: Lymph Node or Core Needle Biopsy","Procedure: Fine Needle Aspiration","Diagnostic Test: Tiny Isothermal Nucleic acid Amplification System (TINY)",[57,62,66],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":39},"PROCEDURE","Lymph Node or Core Needle Biopsy","DNA isolation to be tested by nucleic acid amplification using the TINY device",[49],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":39},"Fine Needle Aspiration","The sample will be eluted into two tubes, one for Gene Xpert testing and one for storage for EBV and KSHV testing by qPCR and TINY.",[49],{"type":67,"name":68,"description":68,"armGroupLabels":69,"otherNames":39},"DIAGNOSTIC_TEST","Tiny Isothermal Nucleic acid Amplification System (TINY)",[49],[71],{"name":72,"affiliation":73,"role":74},"Michael Painschab, MD","IUSCCC","PRINCIPAL_INVESTIGATOR",[76,81],{"name":77,"role":78,"phone":79,"phoneExt":39,"email":80},"Matthew Painschab, MD","CONTACT","(317) 278-0626","mapain@iu.edu",{"name":82,"role":78,"phone":83,"phoneExt":39,"email":84},"Yuri Fedoriw, MD","1 984-974-8320","Yuri.Fedoriw@unchealth.unc.edu",[86],{"facility":87,"status":88,"city":89,"state":39,"zip":39,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Lighthouse Trust HIV Centers of Excellence","RECRUITING","Lilongwe","Malawi","MW",{"type":93,"coordinates":94},"Point",[95,96],33.78725,-13.96692,{"lat":96,"lon":95},[99],{"name":100,"role":78,"phone":101,"phoneExt":39,"email":102},"Shiraz Khan, MBBS","265 999760776","skhan@unclilongwe.org",{"type":74,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Matthew Painschab","Associate Professor of Medicine",[107,109],{"name":108,"class":6},"UNC Lineberger Comprehensive Cancer Center",{"name":110,"class":111},"National Institutes of Health (NIH)","NIH","100653938","new-approaches-for-the-diagnosis-of-lymphoma-and-multicentric-castleman-disease-100653938",false,"NCT07793006","New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease","Inclusion Criteria:\n\n* Age ≥1 year old and body weight of ≥ 10 kg.\n* HIV-infected.\n* Unexplained lymphadenopathy with at least one lymph node ≥2 cm that is amenable to biopsy.\n* Willing and able to give informed consent if the subject is 18 years of age or older, adolescent assent and legal guardian consent for subjects 15-17 years of age, pediatric assent and legal guardian consent for subjects 7-14 years of age, or legal guardian consent for pediatric subjects less than 7 years of age.\n\nExclusion Criteria:\n\n* Cannot or is not willing to follow study procedures.\n* Subjects with a previous history of cancer in the last five years with the exception of subjects with Kaposi sarcoma (i.e. history of Kaposi sarcoma is allowed in the study).","ALL","1 Year",{"count":121,"type":122},500,"ESTIMATED","INTERVENTIONAL",[41],"Persons living with HIV (PLWH) in sub-Saharan Africa (SSA), lymphadenopathy often portends one of a number of life-threatening diseases including tuberculosis, lymphoma, and multicentric Castleman disease (MCD). Overcoming these delays and missed diagnoses requires new approaches to identify lymphoma and MCD.",[127,128,129,130,131,132],"HIV","Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease","Hodgkin Lymphoma","Non-Hodgkin Lymphoma","Tiny Isothermal Nucleic Acid Amplification System","Lymphadenopathy",[134],"Sub-Saharan Africa","2026-08-25",{"date":137,"type":138},"2026-08-28","ACTUAL",{"date":140,"type":138},"2025-03-17",{"date":142,"type":122},"2028-12",{"name":5,"class":6},1]