The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project
Official Title: A Disease Registry for Patients With Tenosynovial Giant Cell Tumors (TGCT), Also Known as Pigmented Villonodular Synovitis (PVNS) and Giant Cell Tumor of the Tendon Sheath (GCT-TS)
Study ID: NCT02948088
Brief Summary: TGCT is a rare disease that is difficult to manage, surgical resection is the primary treatment currently available. To date no disease registry exists and there is little data available detailing the management of patients with diffuse TGCT (d-TGCT), the burden of d-TGCT for patients (including pain, joint stiffness, swelling, reduced mobility and quality of life) or the economic impact of d-TGCT. This study aims to collect data by an observational disease registry involving no intervention to the patient or changes to investigators treatment decisions.
Detailed Description: GCT is a rare, benign, but potentially locally aggressive and recurrent disease. Treatment pattern and treatment initiation, continuation or changes are solely at the discretion of the physician and the patient. 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, Milano, , Italy
Leiden University Medical Center, Leiden, , Netherlands
Radboud universitair medisch centrum, Nijmegen, , Netherlands
Hospital Sant Pau, Barcelona, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
The Royal Marsden Hospital, London, , United Kingdom
Nuffield Orthopaedic Centre, Oxford, , United Kingdom
Name: Global Clinical Leader
Affiliation: Daiichi Sankyo
Role: STUDY_DIRECTOR