Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
NCT ID: NCT03435796
Last Updated: 2026-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
1541 participants
INTERVENTIONAL
2018-07-19
2036-11-30
Brief Summary
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Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Participants exposed to Gene-modified (GM) T cell therapy
Gene-modified (GM) T cell therapy
No investigational product will be administered
Interventions
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Gene-modified (GM) T cell therapy
No investigational product will be administered
Eligibility Criteria
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Inclusion Criteria
* Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.
Exclusion Criteria
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic Phoenix
Phoenix, Arizona, United States
Arizona Cancer Center
Scottsdale, Arizona, United States
Local Institution - 01021
Tucson, Arizona, United States
City Of Hope
Duarte, California, United States
University Of California San Diego Moores Cancer Center
La Jolla, California, United States
Local Institution - 01206
Los Angeles, California, United States
Local Institution - 01043
Sacramento, California, United States
University of California, San Francisco- California
San Francisco, California, United States
UCLA Medical Centre-Santa Monica
Santa Monica, California, United States
Stanford Cancer Center
Stanford, California, United States
University Of Colorado Cancer Center
Aurora, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Local Institution - 01050
Washington D.C., District of Columbia, United States
The Mayo Clinic - Jacksonville, Davis-E
Jacksonville, Florida, United States
Baptist Cancer Center
Miami, Florida, United States
Local Institution - 01035
Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute University of South Florida
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Northside Hospital, Inc
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University Of Chicago Medical Center
Chicago, Illinois, United States
Local Institution - 01040
Maywood, Illinois, United States
Local Institution - 01063
Niles, Illinois, United States
IN Univ Simon Cancer Center
Indianapolis, Indiana, United States
Local Institution - 01020
Indianapolis, Indiana, United States
Kansas University Medical Center
Westwood, Kansas, United States
Cancer Center of Kansas
Wichita, Kansas, United States
University Of Kentucky
Lexington, Kentucky, United States
Norton Cancer Institute Louisville Oncology
Louisville, Kentucky, United States
Local Institution - 01026
New Orleans, Louisiana, United States
University of Maryland - Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Sidney Kimmel Comp Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
National Cancer Institute
Bethesda, Maryland, United States
Local Institution - 01107
Boston, Massachusetts, United States
Massachusetts General Hospital / Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Local Institution - 01106
Boston, Massachusetts, United States
University Of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Karmanos Cancer Center Wayne State University
Detroit, Michigan, United States
Providence Cancer Institute
Southfield, Michigan, United States
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Siteman Cancer Center
St Louis, Missouri, United States
University Of Nebraska Medical Center
Omaha, Nebraska, United States
Local Institution - 01030
East Brunswick, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Morristown Memorial Hosp
Morristown, New Jersey, United States
Local Institution - 01053
New Brunswick, New Jersey, United States
New York Oncology Hematology P.C.
Albany, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Local Institution - 01066
New York, New York, United States
Weill Cornell Medicine / New York Presbyterian Hospital
New York, New York, United States
Icahn School Of Medicine At Mount Sinai
New York, New York, United States
Columbia University Medical Center/New York-Presbyterian Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Local Institution - 01051
Rochester, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Novant Health
Salisbury, North Carolina, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute
Eugene, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Oregon Health and Science University OHSU
Portland, Oregon, United States
Children's Hospital of Philadelphia-Center for Childhood Cancer Research
Philadelphia, Pennsylvania, United States
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Thomas Jefferson University - Clinical Research Institute
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, United States
Hematology and Oncology Associates of SC, LLC
Greenville, South Carolina, United States
Local Institution - 01064
Sioux Falls, South Dakota, United States
Sarah Cannon Research Inst
Nashville, Tennessee, United States
Texas Oncology
Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Texas- MD Anderson
Houston, Texas, United States
Sam Clinical Research Center
San Antonio, Texas, United States
Local Institution - 01033
Temple, Texas, United States
Texas Oncology, P.A. - Tyler
Tyler, Texas, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States
Intermountain Healthcare - LDS Hospital
Salt Lake City, Utah, United States
University Of Virginia Health System
Charlottesville, Virginia, United States
Local Institution - 01045
Norfolk, Virginia, United States
Local Institution - 01023
Richmond, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
Local Institution - 01060
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Local Institution - 01055
Tacoma, Washington, United States
University Of Wisconsin
Madison, Wisconsin, United States
Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Local Institution - 01069
Wauwatosa, Wisconsin, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien
Vienna, , Austria
Jules Bordet Institut
Anderlecht, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Local Institution - 05200
Ghent, , Belgium
Uz Gent
Ghent, , Belgium
University Hospital Leuven
Leuven, , Belgium
Local Institution - UNK 2
Leuven, , Belgium
University Of Calgary
Calgary, Alberta, Canada
Local Institution - 02802
Vancouver, British Columbia, Canada
Local Institution - 02801
Hamilton, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
CIUSSS de l'Est-de-l'Ile-de-Montreal
Montreal, Quebec, Canada
Helsinki University Central Hospital (HUCH)
Helsinki, , Finland
Hopital Henri Mondor
Creteil-Paris, , France
CHRU de Lille France
Lille, , France
Local Institution - 09601
Lyon, , France
Local Institution - 09400
Marseille, , France
Local Institution - 09602
Marseille, , France
CHU Montpellier - Hôpital Saint Eloi
Montpellier, , France
Chu Hotel Dieu
Nantes, , France
Hopital Saint Louis
Paris, , France
Hospital Saint Louis
Paris, , France
Local Institution - 09600
Paris, , France
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Haut-Leveque
Pessac, , France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
CHU La Miletrie
Poitiers, , France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, , France
Gustave Roussy
Villejuif, , France
Robert-Rossle-Klinik im HELIOS Klinikum Berlin-Buch Klinik fur Hamatologie, Onkologie u. Tumorimmuno
Berlin, , Germany
Local Institution - 03155
Berlin, , Germany
Kinikum der Universitaeat zu Koeln
Cologne, , Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden
Dresden, , Germany
Local Institution - 03513
Düsseldorf, , Germany
Local Institution - 03500
Frankfurt, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitatsklinikum Heidelberg
Heidelberg, , Germany
LMU Klinikum der Universität
München, , Germany
Local Institution - 03454
Münster, , Germany
Local Institution - 03503
Tübingen, , Germany
University Hospital of Ulm
Ulm, , Germany
Universitatsklinikum Wurzburg Medizinische Klinik und Poliklinik II
Würzburg, , Germany
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Ospedali Riuniti di Ancona
Ancona, , Italy
Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi
Bologna, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Fondazione Monza e Brianza per il Bambino e la sua Mamma (MBBM)
Monza, , Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Naples, , Italy
Local Institution - 07500
Roma, , Italy
Ospedale Pediatrico Bambino Gesu
Rome, , Italy
Istituto Clinico Humanitas
Rozzano (MI), , Italy
Local Institution - 07610
Torino, , Italy
Azienda Sanitaria Ospedaliera San Giovanni Battista Molinette
Turin, , Italy
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Toranomon Hospital
Minato-ku, Tokyo, Japan
Local Institution - 13202
Bunkyō City, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Tokai University Hospital
Isehara City, Kanagawa, , Japan
Nagoya City University Hospital
Nagoya, , Japan
Osaka Metropolitan university Hospital
Osaka, , Japan
Japan Red Cross Medical Center
Shibuya-ku, , Japan
Local Institution - 13804
Shinjuku, , Japan
Local Institution - 04650
Amsterdam, , Netherlands
Erasmus Medical Center - Daniel den Hoed
Rotterdam, , Netherlands
Local Institution - 04400
Utrecht, , Netherlands
Oslo Universitetssykehus
Oslo, , Norway
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
St Johns Cancer Centre in Lublin
Lublin, , Poland
Instytut Hematologii I Transfuzjologii
Warsaw, , Poland
Institutul Clinic Fundeni
Bucharest, , Romania
Asan Medical Center (AMC)
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Universitario Vall D hebron
Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol ICO Badalona
Barcelona, , Spain
Institut Clinic de Nefrologia i Urologia - Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital San Joan de Deu Barcelona
Esplugues de Llobregat, , Spain
Hospital Infantil Universitario Nino Jesus
Madrid, , Spain
Hospital 12 De Octubre
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, , Spain
Hospital Virgen Del Rocio
Seville, , Spain
Karolinska University Hospital Huddinge
Stockholm, , Sweden
Inselspital Bern
Bern, , Switzerland
Local Institution - 10850
Leeds, , United Kingdom
Kings College Hospital
London, , United Kingdom
UCL Cancer Institute
London, , United Kingdom
Christie Hospital Nhs Trust
Manchester Withington, , United Kingdom
Somers Cancer Research Building
Shirley Southampton, , United Kingdom
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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Luciano Costa, Site 01171
Role: primary
Rajneesh Nath, Site 01049
Role: primary
Jeremy Larsen, Site 01200
Role: primary
Adrienne Briggs, Site 01039
Role: primary
Tanya Siddiqi, Site 01011
Role: primary
Thomas Kipps, Site 01019
Role: primary
Charalambos Andreadis, Site 01108
Role: primary
Sarah Larson, Site 01184
Role: primary
Michaela Liedtke, Site 01119
Role: primary
Manali Kamdar, Site 01208
Role: primary
Tara Gregory, Site 01212
Role: primary
Iris Isufi, Site 01059
Role: primary
Sikander Ailawadhi, Site 01201
Role: primary
Yuliya Linhares, Site 01047
Role: primary
Melissa Alsina, Site 01153
Role: primary
Sagar Lonial, Site 01103
Role: primary
Scott Solomon, Site 01207
Role: primary
Reem Karmali, Site 01014
Role: primary
Peter Riedell, Site 01018
Role: primary
Rafat Abonour, Site 01161
Role: primary
Al-Ola Abdallah, Site 01174
Role: primary
Bassam Mattar, Site 01031
Role: primary
Chaitanya Iragavarapu, Site 01046
Role: primary
Don Stevens, Site 01032
Role: primary
Mehmet Kocoglu, Site 01164
Role: primary
Syed Abbas Ali, Site 01017
Role: primary
James Kochenderfer, Site 01114
Role: primary
Jeremy Abramson, Site 01012
Role: primary
Monalisa Ghosh, Site 01024
Role: primary
Abhinav Deol, Site 01025
Role: primary
Leo Reap, Site 01056
Role: primary
Veronika Bachanova, Site 01112
Role: primary
Yi Lin, Site 01105
Role: primary
Ravi Vij, Site 01176
Role: primary
Matthew Lunning, Site 01015
Role: primary
David Siegel, Site 01102
Role: primary
Mohamad Cherry, Site 01027
Role: primary
Courtney Bellomo, Site 01041
Role: primary
Francisco Hernandez-Ilizaliturri, Site 01111
Role: primary
Roger Niles Pearse, Site 01198
Role: primary
Sundar Jagannath, Site 01109
Role: primary
Ran Reshef, Site 01209
Role: primary
Maria Palomba, Site 01177
Role: primary
Bei Hu, Site 01204
Role: primary
Taewoong Choi, Site 01175
Role: primary
Alan Skarbnik, Site 01058
Role: primary
James Essell, Site 01037
Role: primary
Leland Metheny, Site 01042
Role: primary
Brian Hill, Site 01062
Role: primary
Srinivas Devarakonda, Site 01074
Role: primary
Adam Asch, Site 01038
Role: primary
Jeff Sharman, Site 01052
Role: primary
Stacy Lewis, Site 01028
Role: primary
Richard Maziarz, Site 01022
Role: primary
Stephan Grupp, Site 01061
Role: primary
Stephen Schuster, Site 01016
Role: primary
Xia Bi, Site 01173
Role: primary
Asya Varshavsky-Yanovsky, Site 01172
Role: primary
Alison Sehgal, Site 01210
Role: primary
Saeeda Chowdhury, Site 01034
Role: primary
Jesus Berdeja, Site 01101
Role: primary
Jay Courtright, Site 01044
Role: primary
Houston Holmes, Site 01180
Role: primary
Larry Anderson, Site 01104
Role: primary
Maureen Mayes, Site 01215
Role: primary
Hun Lee, Site 01013
Role: primary
Paul Shaughnessy, Site 01211
Role: primary
Habte Yimer, Site 01054
Role: primary
Douglas Sborov, Site 01199
Role: primary
Dannish Hoda, Site 01029
Role: primary
Indumathy Varadarajan, Site 01065
Role: primary
Daniel Egan, Site 01166
Role: primary
Jordan Gauthier, Site 01110
Role: primary
Natalie Callander, Site 01036
Role: primary
Meera Mohan, Site 01178
Role: primary
Site 01069
Role: primary
Simon Harrison, Site 16001
Role: primary
Shafqat Inam, Site 16004
Role: primary
Stephanie Lam, Site 16006
Role: primary
Ulrich Jaeger, Site 12101
Role: primary
Marie Vercruyssen, Site 05202
Role: primary
Ann De Becker, Site 05203
Role: primary
Fritz Offner, Site 05351
Role: primary
Michel Delforge, Site 05201
Role: primary
Nizar Bahlis, Site 02302
Role: primary
Christine Chen, Site 02301
Role: primary
Isabelle Fleury, Site 02800
Role: primary
Sirpa Leppa, Site 11551
Role: primary
Karim BELHADJ-MERZOUG, Site 09211
Role: primary
Ibrahim YAKOUB-AGHA, Site 09202
Role: primary
Guillaume Cartron, Site 09206
Role: primary
Philippe Moreau, Site 09401
Role: primary
Bertrand Arnulf, Site 09204
Role: primary
Catherine Thieblemont, Site 09207
Role: primary
Cyrille Hulin, Site 09210
Role: primary
Herve Ghesquieres, Site 09201
Role: primary
xavier leleu, Site 09203
Role: primary
Aurore Perrot, Site 09205
Role: primary
Vincent Ribrag, Site 09402
Role: primary
Bertram Glass, Site 03451
Role: primary
Site 03155
Role: primary
Peter Borchmann, Site 03151
Role: primary
Martin Wermke, Site 03152
Role: primary
Francis Ayuk, Site 03452
Role: primary
Hartmut Goldschmidt, Site 03502
Role: primary
Marion Subklewe, Site 03154
Role: primary
Andreas Viardot, Site 03153
Role: primary
Hermann Einsele, Site 03501
Role: primary
Ron Ram, Site 18005
Role: primary
Hila Magen, Site 18003
Role: primary
Federico Lussana, Site 07602
Role: primary
Michele Cavo, Site 07601
Role: primary
Paolo Corradini, Site 07402
Role: primary
Adriana Balduzzi, Site 07301
Role: primary
Antonio Pinto, Site 07303
Role: primary
Franco Locatelli, Site 07300
Role: primary
Armando Santoro, Site 07501
Role: primary
Barbara Botto, Site 07401
Role: primary
Hideki Goto, Site 13806
Role: primary
Yoshinobu Kanda, Site 13802
Role: primary
Koji Izutsu, Site 13601
Role: primary
Go Yamamoto, Site 13602
Role: primary
Koji Kato, Site 13805
Role: primary
Yoshiaki Ogawa, Site 13803
Role: primary
Shinsuke Iida, Site 13807
Role: primary
Yasuhiro Nakashima, Site 13203
Role: primary
Kenshi Suzuki, Site 13801
Role: primary
Pim Mutsaers, Site 04301
Role: primary
Ingerid Abrahamsen, Site 14001
Role: primary
Jan Zaucha, Site 22006
Role: primary
Wojciech Legiec, Site 22004
Role: primary
Ewa Lech-Maranda, Site 22003
Role: primary
Alina Tanase, Site 23001
Role: primary
Dok Hyun Yoon, Site 17003
Role: primary
Kihyun Kim, Site 17001
Role: primary
Chang Ki Min, Site 17002
Role: primary
Pere Barba Suñol, Site 08451
Role: primary
Albert Oriol Rocafiguera, Site 08702
Role: primary
Armando Lopez Guillermo, Site 08600
Role: primary
Susana Rives, Site 08251
Role: primary
Alba Rubio, Site 08252
Role: primary
Joaquin Martinez Lopez, Site 08601
Role: primary
Paula Rodriguez Otero, Site 08701
Role: primary
Maria Victoria Mateos Manteca, Site 08751
Role: primary
Delgado Javier, Site 08253
Role: primary
Stephan Mielke, Site 15001
Role: primary
Urban Novak, Site 06251
Role: primary
Reuben BEnjamin, Site 10851
Role: primary
Claire Roddie, Site 10501
Role: primary
Kim Linton, Site 10502
Role: primary
Andrew Davies, Site 10500
Role: primary
References
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Abramson JS, Palomba ML, Gordon LI, Lunning M, Wang M, Arnason J, Purev E, Maloney DG, Andreadis C, Sehgal A, Solomon SR, Ghosh N, Dehner C, Kim Y, Ogasawara K, Kostic A, Siddiqi T. Two-year follow-up of lisocabtagene maraleucel in relapsed or refractory large B-cell lymphoma in TRANSCEND NHL 001. Blood. 2024 Feb 1;143(5):404-416. doi: 10.1182/blood.2023020854.
Related Links
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BMS Clinical Trial Information
Other Identifiers
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U1111-1206-8250
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-504201-36
Identifier Type: OTHER
Identifier Source: secondary_id
GC-LTFU-001
Identifier Type: -
Identifier Source: org_study_id
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