[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100442827":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":22,"locations":32,"responsibleParty":47,"collaborators":49,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":10,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Munich Leukemia Laboratory","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Unclear diagnosis via conventional methods",null,"The study population consists of carefully chosen patients with potential hematological malignancy, for which current diagnostic methods were not sufficient to provide clear-cut diagnosis and definitive clinical guidance. SIRIUS will be conducted for a total number of 110 patients with inconclusive diagnosis by gold standard techniques for a total of up to nine months after the first enrollment.",[13],"Diagnostic Test: Next Generation Sequencing",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Next Generation Sequencing","NON-Interventional Observation only study comparing sequencing-only approaches to classical diagnostic methods",[9],[21],"NGS, Whole genome Sequencing",[23,28],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},"Torsten Haferlach, MD","CONTACT","+49 (0)89 99017-100","torsten.haferlach@mll.com",{"name":29,"role":25,"phone":30,"phoneExt":10,"email":31},"Adam Wahida, MD","004917664982845","adam.wahida@tum.de",[33],{"facility":34,"status":35,"city":36,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"MLL Munich Leukemia Laboratory","RECRUITING","Munich","Germany","DE",{"type":40,"coordinates":41},"Point",[42,43],11.57549,48.13743,{"lat":43,"lon":42},[46],{"name":24,"role":25,"phone":10,"phoneExt":10,"email":10},{"type":48,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[50],{"name":51,"class":6},"Illumina, Inc.","100442827","solving-riddles-through-sequencing-100442827",false,"NCT05046444","Solving Riddles Through Sequencing","Testing the Diagnostic Supremacy of Sequencing-only Approaches in Hematologic Malignancies: an Observational Trial","SIRIUS","Inclusion Criteria:\n\n* Patients having been investigated with a suspected hematological disorder and:\n* Having unclear diagnosis after internal routine diagnosis\n* Unusual clinical course\n* Unusual r\u002Fr status or non-responder\n* Multiple parallel hematological conditions\n* Difficult\u002Frare therapy associated\u002Fsecondary neoplasms\n* Current diagnostic workup is not satisfactory in terms of (1) accuracy (2) clinical behavior\n* Only samples of patients min. 18 years of age will be used\n* Material with a minimum of 20% tumor content in bone marrow or peripheral blood sample\n* Patient´s informed consent\n\nExclusion Criteria:\n\n* Sample is not fit for state-of-the-art diagnosis, fails initial quality control. For quality insurance we will exclude samples with wrong anticoagulant sent. Samples with damage due to meteorological reasons (freeze-thaw damage or elevated temperature) will be excluded.\n* Samples with to scarce material jeopardizing routine gold-standard diagnosis will be excluded (tumor content \\\u003C 20 %).","ALL","18 Years","99 Years",{"count":64,"type":65},100,"ESTIMATED","OBSERVATIONAL","During the last decades hematologists have excelled at improving and refining the classification, diagnosis, and thus ultimately the therapeutic decision-making process for their patients. This continuous evolution proceeded in parallel to seminal discoveries in basic science such as FISH, PCR and NGS. So far, the current WHO classification serves as reference to diagnostic decision making and is largely based on 5 diagnostic pillars: cytomorphology of peripheral blood and\u002For bone marrow smears, histology and immunohistochemistry of bone marrow trephine biopsies or lymph nodes, immunophenotyping, chromosome banding analysis supplemented by FISH analysis, molecular genetics including PCR and targeted panel sequencing via NGS. This leads to a swift diagnosis in 90 % of all cases. The leftover 10 % remain a challenge for hematopathologists and clinicians alike and are resolved through interdisciplinary teams in the context of specialized boards. With the advent of high throughput sequencing (mainly WGS and WTS) the possibility of a comprehensive and detailed portrait of the genetic alterations - specifically in challenging cases - has become a realistic alternative to classical methods. In SIRIUS the investigators will prospectively challenge this hypothesis to address the question of how often a better or final diagnosis can be delivered by WGS and\u002For WTS and if unclear cases can be efficiently resolved.",[69,70,71,72,73,74],"Leukemia","Hematologic Malignancy","Rare Diseases","Refractory Leukemia","Refractory Lymphoma","Unknown Primary Tumors","2024-12-14",{"date":77,"type":78},"2024-12-17","ACTUAL",{"date":80,"type":78},"2022-01-19",{"date":82,"type":65},"2026-10-01",{"name":5,"class":6},1]