[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572695":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":117,"collaborators":20,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":20,"eligibilityCriteria":125,"healthyVolunteers":121,"sex":126,"minAge":127,"maxAge":20,"enrollmentInfo":128,"targetDuration":20,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":146,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with Diffuse large B-cell lymphoma (DLBCL) i","EXPERIMENTAL","Participants will be deemed clinically high-risk for CNS relapse. Participants will be considered to be high-risk for CNS relapse as determined by CNS-IPI score, pathological characteristics such as the presence of MYC, BCL2 and\u002For BCL6 translocations and specific extranodal involvement such as breast, renal, adrenal, nasopharyngeal, epidural\u002Fparaspinal involvement",[13],"Diagnostic Test: Cerebral Spinal Fluid ctDNA",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Cerebral Spinal Fluid ctDNA","MSK's Diagnostic Molecular Pathology core has developed and validated a CSF ctDNA assay which has been approved by New York State Department of Health as of 2019",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Jennifer Lue, MD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","646-608-4160","luej@mskcc.org",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Ariela Noy, MD","646-608-3727","noya@MSKCC.ORG",[35,51,62,73,85,96,106],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","RECRUITING","Basking Ridge","New Jersey","07920","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-74.54932,40.70621,{"lat":47,"lon":46},[50],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":52,"status":37,"city":53,"state":39,"zip":54,"country":41,"countryCode":42,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","Middletown","07748",{"type":44,"coordinates":56},[57,58],-74.11709,40.39428,{"lat":58,"lon":57},[61],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":63,"status":37,"city":64,"state":39,"zip":65,"country":41,"countryCode":42,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",{"type":44,"coordinates":67},[68,69],-74.02292,41.04676,{"lat":69,"lon":68},[72],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":74,"status":37,"city":75,"state":76,"zip":77,"country":41,"countryCode":42,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)","Commack","New York","11725",{"type":44,"coordinates":79},[80,81],-73.29289,40.84288,{"lat":81,"lon":80},[84],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":86,"status":37,"city":87,"state":76,"zip":88,"country":41,"countryCode":42,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",{"type":44,"coordinates":90},[91,92],-73.71263,40.96899,{"lat":92,"lon":91},[95],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":97,"status":37,"city":76,"state":76,"zip":98,"country":41,"countryCode":42,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Memorial Sloan Kettering Cancer Center (All Protocol Activites)","10065",{"type":44,"coordinates":100},[101,102],-74.00597,40.71427,{"lat":102,"lon":101},[105],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"facility":107,"status":37,"city":108,"state":76,"zip":109,"country":41,"countryCode":42,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","Rockville Centre","11553",{"type":44,"coordinates":111},[112,113],-73.64124,40.65871,{"lat":113,"lon":112},[116],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":20},{"type":118,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100572695","phase-2-a-study-of-circulating-tumor-dna-ctdna-testing-for-people-with-b-cell-lymphoma-100572695",false,"NCT06736613","A Study of Circulating Tumor DNA (ctDNA) Testing for People With B-Cell Lymphoma","Cerebral Spinal Fluid Circulating Tumor DNA (ctDNA) Analysis in Patients With Aggressive B-cell Lymphoma Receiving Front Line Therapy and at High Risk for Central Nervous System Relapse","Inclusion Criteria:\n\n* Signed Informed Consent.\n* Ability and willingness to comply with the requirements of the study protocol.\n* Age ≥ 18 years old.\n* Diagnosis of the following histologies according to the 2016 WHO Classification for Mature Lymphoid Neoplasms81 along with a specific high-risk criteria for CNS relapse if indicated as certain diagnoses in of themselves are high-risk alone:\n\n  1. Diffuse Large B-cell Lymphoma (DLBCL) with CNS IPI score ≥ 4.\n  2. Stage III\u002FIV High Grade B-cell lymphoma (HGBCL) with MYC, BCL2, and\u002For BCL6 translocations\n  3. Primary DLBCL of Breast\n  4. Primary DLBCL of Testis\n  5. Primary Cutaneous DLBCL, Leg Type\n  6. Intravascular Large B-cell Lymphoma\n  7. Stage III\u002FIV HIV-associated DLBCL\n  8. Double expressor DLBCL (co-expression of MYC ≥ 40% and BCL2 ≥ 50% without translocations) with a CNS IPI score ≥ 3\n  9. DLBCL with the following extranodal involvement AND CNS IPI score ≥ 3:\n\n  i. Adrenal ii. Breast iii. Bone Marrow with pathological overt morphological involvement iv. Epidural\u002FParaspinal v. Nasal\u002Fparasinus with local invasion such as bone destruction vi. Renal viii. Uterine ix. Testis xi. Skull involvement without direct invasion into CNS\u002Fbrain parenchyma\n* Transformed DLBCL from any indolent B-cell lymphoma is permitted (as long as there is no prior history of CNS involvement).\n* Planned to receive standard chemoimmunotherapy.\n* Patient is able to undergo lumbar puncture without any contraindications which include but are not limited to altered mental status, increased intracranial pressure due to any CNS lesion (mass, abscess), overlying skin infection at the site of LP, inability to safely access CSF due to lymphomatous involvement (i.e. epidural mass), or inability to hold antiplatelet or anticoagulation safely for the procedure to be performed.\n* No systemic therapy prior to study enrollment for an aggressive B-cell lymphoma is permitted. Treatment for a history of indolent lymphoma is permitted. Systemic corticosteroids are permitted (must be ≤7 days and tapered down to prednisone ≤ 20 mg oral\u002Fday or steroid equivalent by first day of anthracycline treatment). Clinical exceptions in regards to steroid management can be made after discussion with PI.\n* ECOG performance status of 0 to 2.\n\nExclusion Criteria:\n\n* Active systemic therapy for another malignancy (other than indolent B-cell lymphoma) within 2 years; local\u002Fregional therapy with curative intent such as surgical resection or localized radiation within 2 years of treatment is permitted.\n* Active concurrent malignancy with the exception of basal cell or localized squamous cell skin carcinoma, localized prostate cancer, or other localized carcinomas such as carcinoma in situ of cervix, breast, or bladder.\n* Any uncontrolled illness that in the opinion of the investigator would preclude administration of curative intent chemoimmunotherapy (e.g. significant active infections, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction).\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 2 weeks prior to Cycle 1, Day 1.\n* Psychiatric illness or social situations that would limit the patient's ability to tolerate and\u002For comply with study requirements.","ALL","18 Years",{"count":129,"type":130},50,"ESTIMATED","INTERVENTIONAL",[133],"PHASE2","The purpose of this study is to find out how many people with B-cell lymphoma who are at high risk for central nervous system\u002FCNS relapse test positive for cerebral spinal fluid\u002FCSF ctDNA but test negative for CNS involvement using standard tests. The study will also look at how often CNS relapse happens in people with and without detected CSF ctDNA.",[136,137,138,139,140,141,142,143,144,145],"Diffuse Large B Cell Lymphoma","High-grade B-cell Lymphoma","Stage III High Grade B-Cell Lymphoma","Stage IV High Grade B-Cell Lymphoma","DLBCL - Diffuse Large B Cell Lymphoma","Intravascular Large B-Cell Lymphoma","Diffuse Large B Cell Lymphoma of Breast","Diffuse Large B Cell Lymphoma of Testis","HIV-associated Diffuse Large B Cell Lymphoma","Double Expressor DLBCL",[136,137,138,139,140,141,142,143,144,147,148,149,5,150],"Double expressor DLBCL","Circulating Tumor DNA","ctDNA","24-336","2025-12-17",{"date":153,"type":154},"2025-12-18","ACTUAL",{"date":156,"type":154},"2024-12-11",{"date":158,"type":130},"2027-12-11",{"name":5,"class":6},7]