Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project
NCT ID: NCT02948088
Last Updated: 2023-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
183 participants
OBSERVATIONAL
2016-11-18
2021-03-11
Brief Summary
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This study aims to collect data by an observational disease registry involving no intervention to the patient or changes to investigators treatment decisions.
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Detailed Description
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There will be no attempt to influence the prescribing patterns of any individual treating physician. All medication will be prescribed in the usual standard of care and will not be provided by the study sponsor.
Participation in the study will in no way influence payment or reimbursement for any treatment received by patients during the study.
It is the responsibility of the investigator and his study staff to enter all relevant patient data required for this registry in the electronic Case Report Form (eCRF) and in the patients' medical records.
Approximately 15 sites from up to 6 European Countries (France, Germany, Italy, The Netherlands, Spain and United Kingdom) and 4 sites from the US are planned to participate. The sites will be specialized sites that treat d-TGCT regularly.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients with d-TGCT (diagnosed histologically) confirmed naïve or recurrent case
18 Years
ALL
No
Sponsors
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Optimapharm
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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David Geffen School of Medicine at UCLA
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Medizinische Universität Graz
Graz, , Austria
CHU Nantes
Nantes, , France
Westdeutsches Tumorzentrum
Essen, , Germany
Istituto Ortopedico Rizzoli
Bologna, , Italy
Istituto Nazionale Tumori-Foundazione IRCCS
Milan, , Italy
Leiden University Medical Center
Leiden, , Netherlands
Radboud universitair medisch centrum
Nijmegen, , Netherlands
Hospital Sant Pau
Barcelona, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
The Royal Marsden Hospital
London, , United Kingdom
Nuffield Orthopaedic Centre
Oxford, , United Kingdom
Countries
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References
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Palmerini E, Healey JH, Bernthal NM, Bauer S, Schreuder H, Leithner A, Martin-Broto J, Gouin F, Lopez-Bastida J, Gelderblom H, Staals EL, Mercier F, Laeis P, Ye X, van de Sande M. Tenosynovial Giant Cell Tumor Observational Platform Project (TOPP) Registry: A 2-Year Analysis of Patient-Reported Outcomes and Treatment Strategies. Oncologist. 2023 Jun 2;28(6):e425-e435. doi: 10.1093/oncolo/oyad011.
Bernthal NM, Spierenburg G, Healey JH, Palmerini E, Bauer S; TOPP Study Group; Gelderblom H, Staals EL, Lopez-Bastida J, Fronk EM, Ye X, Laeis P, van de Sande MAJ. The diffuse-type tenosynovial giant cell tumor (dt-TGCT) patient journey: a prospective multicenter study. Orphanet J Rare Dis. 2021 Apr 29;16(1):191. doi: 10.1186/s13023-021-01820-6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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DS-ONC-01-15-EU
Identifier Type: -
Identifier Source: org_study_id
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