Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/19/2019 |
| Start Date: | November 2016 |
| End Date: | June 2021 |
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)
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, the burden of diffuse TGCT
for patients (including pain, joint stiffness, swelling, reduced mobility and quality of
life) or the economic impact of diffuse TGCT.
This study aims to collect data by an observational disease registry involving no
intervention to the patient or changes to investigators treatment decisions.
treatment currently available. To date no disease registry exists and there is little data
available detailing the management of patients with diffuse TGCT, the burden of diffuse TGCT
for patients (including pain, joint stiffness, swelling, reduced mobility and quality of
life) or the economic impact of diffuse TGCT.
This study aims to collect data by an observational disease registry involving no
intervention to the patient or changes to investigators treatment decisions.
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 diffuse TGCT regularly.
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 diffuse TGCT regularly.
Inclusion Criteria:
- Written informed consent for participation in the study (ICF)
- Patients with diffuse TGCT (diagnosed histologically) confirmed naïve or recurrent
case
Exclusion Criteria:
We found this trial at
6
sites
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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10833 Le Conte Ave
Los Angeles, California 90095
Los Angeles, California 90095
(310) 825-4321
Phone: 424-259-9860
David Geffen School of Medicine, UCLA In 2002 Mr. David Geffen announced a $200 million...
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 212-639-7610
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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