[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05978141":3,"trial-entities:NCT05978141":413,"trial-summary:NCT05978141":436},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":49,"study_type":53,"primary_purpose":15,"phases":54,"enrollment_info":55,"interventions":58,"primary_outcomes":64,"secondary_outcomes":69,"sex":70,"minimum_age":15,"maximum_age":15,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":110,"locations":114,"central_contacts":399,"overall_officials":406,"references":409,"see_also_links":410},"NCT05978141","23-190","A Registry for People With T-cell Lymphoma","The T-cell Lymphoma Master Repository (TCLMR): A Prospective Databank of Patients With T-cell Lymphoma With Clinical Annotation and Matched Tumor Specimens","RECRUITING","2030-07-27","2026-05","2026-05-20","2023-07-27","Memorial Sloan Kettering Cancer Center","OTHER",null,"The purpose of this registry study is to create a database-a collection of information-for better understanding T-cell lymphoma. Researchers will use the information from this database to learn more about how to improve outcomes for people with T-cell lymphoma.",[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48],"T-cell Lymphoma","NK-Cell Lymphoma","T-cell Prolymphocytic Leukemia","T-cell Large Granular Lymphocytic Leukemia","Chronic Lymphoproliferative Disorder of NK Cells","Aggressive NK-cell Leukemia","Systemic Epstein-Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood (Disorder)","Systemic Epstein Barr Virus Positive T-Cell Lymphoproliferative Disease of Childhood","Chronic Active EBV Infection of T-and NK-Cell Type, Systemic Form","Hydroa Vacciniforme-Like Lymphoproliferative Disorder","Adult T-cell Leukemia\u002FLymphoma","Extranodal NK\u002FT-cell Lymphoma, Nasal Type","Enteropathy-associated T-cell Lymphoma","Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma","Intestinal T-Cell Lymphoma, Not Otherwise Specified","Indolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal Tract","Hepatosplenic T-cell Lymphoma","Subcutaneous Panniculitis-Like T-Cell Lymphoma","Mycosis Fungoides","Sezary Syndrome","Primary Cutaneous Anaplastic Large Cell Lymphoma","Primary Cutaneous T-cell Lymphoma","Primary Cutaneous CD8-Positive Aggressive Epidermotropic T-Cell Lymphoma","Primary Cutaneous Acral CD8-Positive T-Cell Lymphoma","Peripheral T-Cell Lymphoma, Not Otherwise Specified","Angioimmunoblastic T-cell Lymphoma","Follicular T-Cell Lymphoma","Nodal Peripheral T-Cell Lymphoma With TFH Phenotype","Anaplastic Large Cell Lymphoma, ALK-Positive","Anaplastic Large Cell Lymphoma, ALK-negative","Breast Implant-Associated Anaplastic Large Cell Lymphoma",[5,50,13,51,52],"T-cell lymphoma","T-cell Lymphoma Master Repository","TCLMR","OBSERVATIONAL",[],{"count":56,"type":57},1000,"ESTIMATED",[59],{"type":14,"name":60,"description":61,"armGroupLabels":62},"Optional Blood Sample and Nail Sample","Participants may provide optional research blood and nail samples for biobanking and future use",[63],"Participants with T-Cell Lymphoma",[65],{"measure":66,"description":67,"timeFrame":68},"Number of participants populating the T-cell Lymphoma Master Repository\u002FTCLMR","To develop and populate a secure database comprised of patients with T-cell lymphomas with curated clinical characteristics and treatment outcomes matched to pathological biospecimens.","10 years",[],"ALL",false,{"inclusion":73,"exclusion":106,"raw_text":109},[74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105],"Written informed consent","Adequate fresh or archival tumor biopsy or intent to obtain fresh tumor biopsy.","Pathologically-confirmed mature T- or natural killer (NK)-cell lymphoma meeting one of the following diagnostic criterion (based on WHO classification and NCCN guidelines):","T-cell prolymphocytic leukemia","T-cell large granular lymphocytic leukemia","Chronic lymphoproliferative disorder of NK cells","Aggressive NK-cell leukemia","Systemic Epstein-Barr virus (EBV)-positive T-cell lymphoma of childhood","Chronic active EBV infection of T- and NK-cell type, systemic form","Hydroa vacciniforme-like lymphoproliferative disorder","Adult T-cell leukemia\u002Flymphoma","Extranodal NK\u002FT-cell lymphoma, nasal type","Enteropathy-associated T-cell lymphoma","Monomorphic epitheliotropic intestinal T-cell lymphoma","Intestinal T-cell lymphoma, not otherwise specified (NOS)","Indolent T-cell lymphoproliferative disorder of the gastrointestinal tract","Hepatosplenic T-cell lymphoma","Subcutaneous panniculitis-like T-cell lymphoma","Mycosis fungoides (limited to those with ≥ stage IB disease and those receiving active therapy)","Sézary syndrome","Primary cutaneous anaplastic large cell lymphoma (receiving systemic therapy)","Primary cutaneous Gamma-Delta T-cell lymphoma","Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma","Primary cutaneous acral CD8+ T-cell lymphoma (receiving systemic therapy)","Peripheral T-cell lymphoma, not otherwise specified","Angioimmunoblastic T-cell lymphoma","Follicular T-cell lymphoma","Nodal peripheral T-cell lymphoma with TFH phenotype","Anaplastic large cell lymphoma, ALK-positive","Anaplastic large cell lymphoma, ALK-negative","Breast-implant associated anaplastic large cell lymphoma.","NOTE: Patients with diagnoses of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and\u002For primary cutaneous acral CD8+ T-cell lymphoma must be receiving systemic therapy.",[107,108],"Patients with of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and\u002For primary cutaneous acral CD8+ T-cell lymphoma not receiving systemic therapy.","Inability to collect prospective data, measure response, or perform adequate follow-up assessments in the clinical judgment of the treating physician. NOTE: Repository participation does not exclude participation in clinical trials, nor does existing clinical trial participation exclude enrollment in the study herein outlined.","Inclusion Criteria:\n\n* Written informed consent\n* Adequate fresh or archival tumor biopsy or intent to obtain fresh tumor biopsy.\n* Pathologically-confirmed mature T- or natural killer (NK)-cell lymphoma meeting one of the following diagnostic criterion (based on WHO classification and NCCN guidelines):\n\n  * T-cell prolymphocytic leukemia\n  * T-cell large granular lymphocytic leukemia\n  * Chronic lymphoproliferative disorder of NK cells\n  * Aggressive NK-cell leukemia\n  * Systemic Epstein-Barr virus (EBV)-positive T-cell lymphoma of childhood\n  * Chronic active EBV infection of T- and NK-cell type, systemic form\n  * Hydroa vacciniforme-like lymphoproliferative disorder\n  * Adult T-cell leukemia\u002Flymphoma\n  * Extranodal NK\u002FT-cell lymphoma, nasal type\n  * Enteropathy-associated T-cell lymphoma\n  * Monomorphic epitheliotropic intestinal T-cell lymphoma\n  * Intestinal T-cell lymphoma, not otherwise specified (NOS)\n  * Indolent T-cell lymphoproliferative disorder of the gastrointestinal tract\n  * Hepatosplenic T-cell lymphoma\n  * Subcutaneous panniculitis-like T-cell lymphoma\n  * Mycosis fungoides (limited to those with ≥ stage IB disease and those receiving active therapy)\n  * Sézary syndrome\n  * Primary cutaneous anaplastic large cell lymphoma (receiving systemic therapy)\n  * Primary cutaneous Gamma-Delta T-cell lymphoma\n  * Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma\n  * Primary cutaneous acral CD8+ T-cell lymphoma (receiving systemic therapy)\n  * Peripheral T-cell lymphoma, not otherwise specified\n  * Angioimmunoblastic T-cell lymphoma\n  * Follicular T-cell lymphoma\n  * Nodal peripheral T-cell lymphoma with TFH phenotype\n  * Anaplastic large cell lymphoma, ALK-positive\n  * Anaplastic large cell lymphoma, ALK-negative\n  * Breast-implant associated anaplastic large cell lymphoma.\n* NOTE: Patients with diagnoses of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and\u002For primary cutaneous acral CD8+ T-cell lymphoma must be receiving systemic therapy.\n\nExclusion Criteria:\n\n* Patients with of mycosis fungoides, primary cutaneous anaplastic large cell lymphoma, and\u002For primary cutaneous acral CD8+ T-cell lymphoma not receiving systemic therapy.\n* Inability to collect prospective data, measure response, or perform adequate follow-up assessments in the clinical judgment of the treating physician. NOTE: Repository participation does not exclude participation in clinical trials, nor does existing clinical trial participation exclude enrollment in the study herein outlined.",[111,112,113],"CHILD","ADULT","OLDER_ADULT",[115,130,141,152,163,175,187,199,210,222,234,246,254,266,278,290,302,311,321,330,340,346,355,367,379,387],{"facility":116,"status":117,"city":118,"state":119,"zip":120,"country":121,"contacts":122,"geoPoint":127},"City of Hope Cancer Center (Data collection only)","NOT_YET_RECRUITING","Duarte","California","91010","United States",[123],{"name":124,"role":125,"phone":126},"Jasmine Zain, MD","CONTACT","626-359-8111",{"lat":128,"lon":129},34.13945,-117.97729,{"facility":131,"status":117,"city":132,"state":119,"zip":133,"country":121,"contacts":134,"geoPoint":138},"UNIVERSITY OF CALIFORNIA SAN DIEGO (Data collection only)","San Diego","92103",[135],{"name":136,"role":125,"phone":137},"Aaron Goodman, MD","858-822-6100",{"lat":139,"lon":140},32.71571,-117.16472,{"facility":142,"status":117,"city":143,"state":119,"zip":144,"country":121,"contacts":145,"geoPoint":149},"University of California San Francisco (Data collection only)","San Francisco","94143",[146],{"name":147,"role":125,"phone":148},"Weiyun Ai, MD","415-353-2421",{"lat":150,"lon":151},37.77493,-122.41942,{"facility":153,"status":117,"city":154,"state":119,"zip":155,"country":121,"contacts":156,"geoPoint":160},"Stanford University Medical Center (Data collection only)","Stanford","94305-5408",[157],{"name":158,"role":125,"phone":159},"Michael Khodadoust, MD","650-725-5071",{"lat":161,"lon":162},37.42411,-122.16608,{"facility":164,"status":117,"city":165,"state":166,"zip":167,"country":121,"contacts":168,"geoPoint":172},"University of Colorado (Data Collection Only)","Aurora","Colorado","80045",[169],{"name":170,"role":125,"phone":171},"Bradley Haverkos, MD","212-639-3983",{"lat":173,"lon":174},39.72943,-104.83192,{"facility":176,"status":117,"city":177,"state":178,"zip":179,"country":121,"contacts":180,"geoPoint":184},"Yale University (Data Collection Only)","New Haven","Connecticut","06511",[181],{"name":182,"role":125,"phone":183},"Francine Foss, MD","203-200-4363",{"lat":185,"lon":186},41.30815,-72.92816,{"facility":188,"status":117,"city":189,"state":190,"zip":191,"country":121,"contacts":192,"geoPoint":196},"University of Miami (Data Collection Only)","Miami","Florida","33136",[193],{"name":194,"role":125,"phone":195},"Jonathan Schatz, MD","305-243-5302",{"lat":197,"lon":198},25.77427,-80.19366,{"facility":200,"status":117,"city":201,"state":190,"zip":202,"country":121,"contacts":203,"geoPoint":207},"Moffitt Cancer Center (Data Collection Only)","Tampa","33612",[204],{"name":205,"role":125,"phone":206},"Lubomir Sokol, MD, PhD","888-663-3488",{"lat":208,"lon":209},27.94752,-82.45843,{"facility":211,"status":117,"city":212,"state":213,"zip":214,"country":121,"contacts":215,"geoPoint":219},"Emory University (Data Collection Only)","Atlanta","Georgia","30322",[216],{"name":217,"role":125,"phone":218},"Pamela Allen, MD, MSc","404-778-0519",{"lat":220,"lon":221},33.749,-84.38798,{"facility":223,"status":117,"city":224,"state":225,"zip":226,"country":121,"contacts":227,"geoPoint":231},"Northwestern Medicine (Data Collection)","Chicago","Illinois","60611",[228],{"name":229,"role":125,"phone":230},"Jaehyuk Choi, MD, PhD","312-695-8106",{"lat":232,"lon":233},41.85003,-87.65005,{"facility":235,"status":117,"city":236,"state":237,"zip":238,"country":121,"contacts":239,"geoPoint":243},"Massachusetts General Hospital (Data Collection Only)","Boston","Massachusetts","02114",[240],{"name":241,"role":125,"phone":242},"Salvia Jain, MD","857-392-4495",{"lat":244,"lon":245},42.35843,-71.05977,{"facility":247,"status":117,"city":236,"state":237,"zip":248,"country":121,"contacts":249,"geoPoint":253},"Dana Farber Cancer Institute (Data Collection Only)","02115",[250],{"name":251,"role":125,"phone":252},"Eric D Jacobsen, MD","877-442-3324",{"lat":244,"lon":245},{"facility":255,"status":117,"city":256,"state":257,"zip":258,"country":121,"contacts":259,"geoPoint":263},"Mayo Clinic (Data Collection Only)","Rochester","Minnesota","55905",[260],{"name":261,"role":125,"phone":262},"Nora Bennani, MD","507-284-2511",{"lat":264,"lon":265},44.02163,-92.4699,{"facility":267,"status":117,"city":268,"state":269,"zip":270,"country":121,"contacts":271,"geoPoint":275},"Washington University (Data Collection Only)","St Louis","Missouri","63110",[272],{"name":273,"role":125,"phone":274},"Neha Mehta-Shah, MD, MSCI","314-747-1171",{"lat":276,"lon":277},38.62727,-90.19789,{"facility":279,"status":117,"city":280,"state":281,"zip":282,"country":121,"contacts":283,"geoPoint":287},"University of Nebraska (Data collection only)","Omaha","Nebraska","68198-7680",[284],{"name":285,"role":125,"phone":286},"Matthew Lunning, DO, FACP","402-559-4000",{"lat":288,"lon":289},41.25626,-95.94043,{"facility":291,"status":8,"city":292,"state":293,"zip":294,"country":121,"contacts":295,"geoPoint":299},"Memorial Sloan Kettering at Basking Ridge (All protocol activities)","Basking Ridge","New Jersey","07920",[296],{"name":297,"role":125,"phone":298},"Steven Horwitz, MD","646-608-2680",{"lat":300,"lon":301},40.70621,-74.54932,{"facility":303,"status":8,"city":304,"state":293,"zip":305,"country":121,"contacts":306,"geoPoint":308},"Memorial Sloan Kettering Monmouth (All protocol activities)","Middletown","07748",[307],{"name":297,"role":125,"phone":298},{"lat":309,"lon":310},40.39428,-74.11709,{"facility":312,"status":8,"city":313,"state":314,"zip":315,"country":121,"contacts":316,"geoPoint":318},"Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities)","Commack","New York","11725",[317],{"name":297,"role":125,"phone":298},{"lat":319,"lon":320},40.84288,-73.29289,{"facility":322,"status":8,"city":323,"state":314,"zip":324,"country":121,"contacts":325,"geoPoint":327},"Memorial Sloan Kettering Westchester (All protocol activities)","Harrison","10604",[326],{"name":297,"role":125,"phone":298},{"lat":328,"lon":329},40.96899,-73.71263,{"facility":331,"status":117,"city":314,"state":314,"zip":332,"country":121,"contacts":333,"geoPoint":337},"Weill Cornell Medical Center (Data Collection Only)","10021",[334],{"name":335,"role":125,"phone":336},"Jia Ruan, MD, PhD","646-962-2064",{"lat":338,"lon":339},40.71427,-74.00597,{"facility":341,"status":8,"city":314,"state":314,"zip":342,"country":121,"contacts":343,"geoPoint":345},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",[344],{"name":297,"role":125,"phone":298},{"lat":338,"lon":339},{"facility":347,"status":8,"city":348,"state":314,"zip":349,"country":121,"contacts":350,"geoPoint":352},"Memorial Sloan Kettering Nassau (All protocol activities)","Uniondale","11553",[351],{"name":297,"role":125,"phone":298},{"lat":353,"lon":354},40.70038,-73.59291,{"facility":356,"status":117,"city":357,"state":358,"zip":359,"country":121,"contacts":360,"geoPoint":364},"Ohio State University (Data Collection Only)","Columbus","Ohio","43210",[361],{"name":362,"role":125,"phone":363},"John Reneau, MD, PhD","614-293-8000",{"lat":365,"lon":366},39.96118,-82.99879,{"facility":368,"status":117,"city":369,"state":370,"zip":371,"country":121,"contacts":372,"geoPoint":376},"University of Pennsylvania (Data Collection Only)","Philadelphia","Pennsylvania","19104",[373],{"name":374,"role":125,"phone":375},"Stefan Barta, MD, MS, MRCPCUK","(215) 316-5151",{"lat":377,"lon":378},39.95238,-75.16362,{"facility":380,"status":117,"city":369,"state":370,"zip":381,"country":121,"contacts":382,"geoPoint":386},"Thomas Jefferson University Hospital (Data collection only)","19107",[383],{"name":384,"role":125,"phone":385},"Pierluigi Porcu, MD","215-955-8874",{"lat":377,"lon":378},{"facility":388,"status":117,"city":389,"state":390,"zip":391,"country":121,"contacts":392,"geoPoint":396},"MD Anderson Cancer Center (Data Collection Only)","Houston","Texas","77030",[393],{"name":394,"role":125,"phone":395},"Swami Iyer, MD","713-352-2952",{"lat":397,"lon":398},29.76328,-95.36327,[400,402],{"name":297,"role":125,"phone":298,"email":401},"horwitzs@MSKCC.ORG",{"name":403,"role":125,"phone":404,"email":405},"Alison Moskowitz, MD","646-608-3726","moskowia@mskcc.org",[407],{"name":297,"affiliation":13,"role":408},"PRINCIPAL_INVESTIGATOR",[],[411],{"label":13,"url":412},"http:\u002F\u002Fwww.mskcc.org",{"nct_id":4,"conditions":414,"biomarkers":435},[415,416,417,48,418,419,420,421,422,423,424,425,426,427,428,31,36,429,430,38,431,432,37,35,433,434],"Adult T-Cell Leukemia\u002FLymphoma","Aggressive NK-Cell Leukemia","Anaplastic Large Cell Lymphoma","Chronic Active EBV Disease","Chronic Lymphoproliferative Disorder of NK-Cells","EBV-Positive T-Cell\u002FNK-Cell Lymphoproliferative Disorder of Childhood","Enteropathy-Associated T-Cell Lymphoma","Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type","Follicular Helper T-Cell Lymphoma, Follicular-Type","Hepatosplenic T-Cell Lymphoma","Hydroa Vacciniforme Lymphoproliferative Disorder","Indolent Clonal T-Cell Lymphoproliferative Disorder of the Gastrointestinal Tract","Intestinal T-Cell Lymphoma","Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma","Nasal Type Extranodal NK\u002FT-Cell Lymphoma","Primary Cutaneous Acral CD8-Positive T-Cell Lymphoproliferative Disorder","Primary Cutaneous CD8-Positive Aggressive Epidermotropic Cytotoxic T-Cell Lymphoma","Primary Cutaneous Gamma-Delta T-Cell Lymphoma","T-Cell Large Granular Lymphocyte Leukemia","T-Cell Prolymphocytic Leukemia",[],{"nct_id":4,"found":437,"summary":438,"prompt_version":448},true,{"design":439,"status":440,"heading":441,"summary":442,"follow_up":443,"word_count":444,"commitments":445,"compensation":446,"drugs_mentioned":447},"This is an observational study aiming to enroll 1000 participants. It is a registry, meaning it collects information without testing a specific treatment.","completed","Registry for T-cell Lymphoma","This study is creating a registry (a collection of information) to better understand T-cell lymphoma, NK-cell lymphoma, T-cell prolymphocytic leukemia, T-cell large granular lymphocytic leukemia, and chronic lymphoproliferative disorder of NK cells. Researchers hope to use this information to improve outcomes for people with these conditions. You might be able to join if you have one of these diagnoses and provide consent. The study is considered successful if 1000 participants contribute to the registry over 10 years. The current recruitment status is unclear.","The primary goal is measured at 10 years, indicating a long-term collection of information.",83,"You would provide written informed consent and an adequate tumor biopsy. You may also be asked to provide optional blood and nail samples for future research.","Not stated in the trial record.",[],"v2"]