N/A
N=183
Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project
Giant Cell Tumors
Bottom Line
View on ClinicalTrials.gov: NCT02948088 ↗Enrolled (actual)
183
Serious AEs
—
Results posted
Oct 2023
Primary outcome: Primary: Number of Participants According to the Management Plan in Patients With Diffuse TGCT (d-TGCT) — 94; NA; NA; NA Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants According to the Management Plan in Patients With Diffuse TGCT (d-TGCT) |
94; NA; NA; NA; 43; 19 | — |
| PRIMARY Number of Participants According to the Current TGCT Treatment Plan in Patients With Diffuse TGCT (d-TGCT) |
79; 77; 105; 97; 85; 65 | — |
| PRIMARY Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT) |
5; 1; 0; 1; 1; 0 | — |
| PRIMARY Number of Participants Based on Status of Treatment Plan in Patients With Diffuse TGCT (d-TGCT) |
50; 9; 9; 44; 50; 23 | — |
| PRIMARY Number of Participants Based on Type of Current TGCT Treatment in Patients With Diffuse TGCT (d-TGCT) |
0; 1; 0; 37; 12; 8 | — |
| PRIMARY Number of Participants Based on Tumor Severity Classification at Baseline Based on MRI in Patients With Diffuse TGCT (d-TGCT) |
66; 90; 20 | — |
| PRIMARY Number of Cases With Complications Due to Surgery in Patients With Diffuse TGCT (d-TGCT) |
9 | — |
| PRIMARY Number of Participants With Tumor Recurrence at Baseline in Patients With Diffuse TGCT (d-TGCT) |
40; 18; 19; 1 | — |
| PRIMARY Time Since Most Recent Tumor Recurrence Until Baseline in Patients With Diffuse TGCT (d-TGCT) |
12.55 | — |
| PRIMARY Time From Baseline to First Tumor Recurrence in Patients With Diffuse TGCT (d-TGCT) |
8.4; 19.0; 14.8 | — |
| PRIMARY Mean Brief Pain Inventory (BPI) Pain Severity and Interference Score From Baseline Through 24 Months |
3.35; 3.12; 3.15; 3.05; 2.60; 2.97 | — |
| PRIMARY Mean Worst Stiffness Score From Baseline Through 24 Months |
4.4; 4.2; 4.2; 4.2; 3.9 | — |
| PRIMARY Mean PROMIS Physical Function Score From Baseline Through 24 Months |
41.9; 41.6; 43.2; 42.2; 43.0 | — |
| SECONDARY Mean EuroQol Questionnaire (EQ) of 5 Dimensions (5D) Index Score and EQ Visual Analog Scale Score From Baseline Through 24 Months |
0.714; 0.742; 0.740; 0.741; 0.746; 69.3 | — |
| SECONDARY Mean Number of General Practitioner, Specialist, or Physical Therapy Visits to Assess the Health Resource Utilization in Patients With Diffuse TGCT Through 24 Months |
3.9; 3.0; 3.8; 3.3; 4.7; 7.0 | — |
| SECONDARY Median Number of Days in Rehabilitation and Work Days Missed in Patients With Diffuse TGCT Through 24 Months |
15; 15; 12; 20; 16; 25.50 | — |
| SECONDARY Overall TGCT Outcome Status in Patients With Diffuse TGCT (d-TGCT) |
39; 107; 20; 10; 21; 18 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Written informed consent for participation in the study (ICF)
- Patients with d-TGCT (diagnosed histologically) confirmed naïve or recurrent case
Exclusion Criteria
- As this is a non interventional study, no explicit exclusion criteria have been defined
Data sourced from ClinicalTrials.gov (NCT02948088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.