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.
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.
Study Type
OBSERVATIONAL
Enrollment
183
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
Number of Participants According to the Management Plan in Patients With Diffuse TGCT (d-TGCT)
The management plan received among the patients was collected from information routinely recorded in the patient files / medical records.
Time frame: Baseline up to end of observation period (approximately 2 years)
Number of Participants According to the Current TGCT Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
The current TGCT treatment plan among the patients was collected from information routinely recorded in the patient files / medical records.
Time frame: Baseline up to end of observation period (approximately 2 years)
Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
Type of treatment plan received among the patients was collected from information routinely recorded in the patient files / medical records.
Time frame: Baseline up to end of observation period (approximately 2 years)
Number of Participants Based on Status of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
The status of treatment plan among the patients was collected from information routinely recorded in the patient files / medical records.
Time frame: Baseline up to end of observation period (approximately 2 years)
Number of Participants Based on Type of Current TGCT Treatment in Patients With Diffuse TGCT (d-TGCT)
Type of current TGCT treatment among the patients was collected from information routinely recorded in the patient files / medical records.
Time frame: Baseline up to end of observation period (approximately 2 years)
Number of Participants Based on Tumor Severity Classification at Baseline Based on MRI in Patients With Diffuse TGCT (d-TGCT)
Tumor severity classification was collected from information routinely recorded in the patient files / medical records. ). Tumor severity classification was based on MRI. In this classification scheme, moderate diffuse TGCT is characterized by intra- and/or extra-articular disease, without or with involvement of muscle/tendinous tissue/ligaments. Severe diffuse TGCT is characterized by intra- and extra-articular involvement and involvement of at least one of the 3 structures (muscle/tendinous tissue/ligaments).
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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
...and 5 more locations
Time frame: at Baseline
Number of Cases With Complications Due to Surgery in Patients With Diffuse TGCT (d-TGCT)
Complications due to surgery were collected from information routinely recorded in the patient files / medical records.
Time frame: at Baseline (prior to any d-TGCT therapy)
Number of Participants With Tumor Recurrence at Baseline in Patients With Diffuse TGCT (d-TGCT)
Tumor recurrence was collected from information routinely recorded in the patient files / medical records.
Time frame: at Baseline
Time Since Most Recent Tumor Recurrence Until Baseline in Patients With Diffuse TGCT (d-TGCT)
Time since most recent tumor recurrence was collected from information routinely recorded in the patient files / medical records.
Time frame: at Baseline
Time From Baseline to First Tumor Recurrence in Patients With Diffuse TGCT (d-TGCT)
Time from baseline to first tumor recurrence was collected from information routinely recorded in the patient files / medical records.
Time frame: Baseline up to end of observation period (approximately 2 years)
Mean Brief Pain Inventory (BPI) Pain Severity and Interference Score From Baseline Through 24 Months
The BPI short form is a self administered questionnaire that assesses severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. The BPI pain severity and interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes), where lower scores indicate better clinical outcome.
Time frame: Baseline up to end of observation period (approximately 2 years)
Mean Worst Stiffness Score From Baseline Through 24 Months
The Worst Stiffness numerical rating scale (NRS) is a one-item self-administered, patient-reported outcome questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranges from 0 ("no stiffness") to 10 ("stiffness as bad as you can imagine"), where lower scores indicate better clinical outcome.
Time frame: Baseline up to end of observation period (approximately 2 years)
Mean PROMIS Physical Function Score From Baseline Through 24 Months
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health. Physical function scores range from 0 (worst physical function) to 100 (best physical function, where higher scores indicate better clinical outcome.
Time frame: Baseline up to end of observation period (approximately 2 years)
Mean EuroQol Questionnaire (EQ) of 5 Dimensions (5D) Index Score and EQ Visual Analog Scale Score From Baseline Through 24 Months
The EQ-5D-5L questionnaire measures the patient's quality of life (QoL) based on the 5 dimensions mobility, self care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D index score ranges from 0 (worst QoL) to 1 (best QoL), where lower scores indicate worse clinical outcome. The EQ-5D VAS reports patient's self rated health ranging from 0 (worst health) to 100 (best health you can imagine), where lower scores indicate worse clinical outcome.
Time frame: Baseline up to end of observation period (approximately 2 years)
Mean Number of General Practitioner, Specialist, or Physical Therapy Visits to Assess the Health Resource Utilization in Patients With Diffuse TGCT Through 24 Months
Health resource utilization was assessed by mean number of general practitioner visits, specialist visits, and physical therapy sessions. In addition, the mean number of days in rehabilitation and the number of work days missed were also reported.
Time frame: 13-24 months before baseline up to end of observation period (approximately 2 years)
Median Number of Days in Rehabilitation and Work Days Missed in Patients With Diffuse TGCT Through 24 Months
The median number of days in rehabilitation and the number of work days missed were also reported.
Time frame: 13-24 months before baseline up to end of observation period (approximately 2 years)
Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT)
TGCT outcome status was collected from information routinely recorded in the patient files / medical records.
Time frame: At end of observation period (approximately 2 years post-baseline)