18 and older, any sex, with Giant Cell Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants According to the Management Plan in Patients With Diffuse TGCT (d-TGCT)Primary· Baseline up to end of observation period (approximately 2 years)
The management plan received among the patients was collected from information routinely recorded in the patient files / medical records.
Any prior or concomitant therapies for managing TGCT-related symptoms
Group
Value
95% CI
Baseline
94
Within 1st Year
NA
Within 2nd Year
NA
Any changes to concomitant therapies for managing TGCT-related symptoms since the last visit
Group
Value
95% CI
Baseline
NA
Within 1st Year
43
Within 2nd Year
19
Any changes to TGCT treatment (including also planned treatments) since the last visit
Group
Value
95% CI
Baseline
NA
Within 1st Year
74
Within 2nd Year
61
Number of Participants According to the Current TGCT Treatment Plan in Patients With Diffuse TGCT (d-TGCT)Primary· Baseline up to end of observation period (approximately 2 years)
The current TGCT treatment plan among the patients was collected from information routinely recorded in the patient files / medical records.
Wait and see
Group
Value
95% CI
Baseline
79
Within 1st Year
77
Within 2nd Year
105
Currently being treated or planned to be treated
Group
Value
95% CI
Baseline
97
Within 1st Year
85
Within 2nd Year
65
Unknown/Missing
Group
Value
95% CI
Baseline
0
Within 1st Year
11
Within 2nd Year
3
Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)Primary· Baseline up to end of observation period (approximately 2 years)
Type of treatment plan received among the patients was collected from information routinely recorded in the patient files / medical records.
Radiotherapy
Group
Value
95% CI
Baseline
5
Within 1st Year
1
Within 2nd Year
0
90Yttrium therapy
Group
Value
95% CI
Baseline
1
Within 1st Year
1
Within 2nd Year
0
Systemic therapy
Group
Value
95% CI
Baseline
48
Within 1st Year
16
Within 2nd Year
8
Surgery
Group
Value
95% CI
Baseline
42
Within 1st Year
40
Within 2nd Year
25
Future surgery required
Group
Value
95% CI
Baseline
5
Within 1st Year
2
Within 2nd Year
0
No current or planned treatment
Group
Value
95% CI
Baseline
79
Within 1st Year
77
Within 2nd Year
105
Unchanged therapy
Group
Value
95% CI
Baseline
0
Within 1st Year
36
Within 2nd Year
35
Number of Participants Based on Status of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)Primary· Baseline up to end of observation period (approximately 2 years)
The status of treatment plan among the patients was collected from information routinely recorded in the patient files / medical records.
Planned
Group
Value
95% CI
Baseline
50
Within 1st Year
9
Within 2nd Year
9
Current
Group
Value
95% CI
Baseline
44
Within 1st Year
50
Within 2nd Year
23
Missing
Group
Value
95% CI
Baseline
5
Within 1st Year
2
Within 2nd Year
0
Number of Participants Based on Type of Current TGCT Treatment in Patients With Diffuse TGCT (d-TGCT)Primary· Baseline up to end of observation period (approximately 2 years)
Type of current TGCT treatment among the patients was collected from information routinely recorded in the patient files / medical records.
90Yttrium therapy
Group
Value
95% CI
Baseline
0
Within 1st Year
1
Within 2nd Year
0
Systemic therapy
Group
Value
95% CI
Baseline
37
Within 1st Year
12
Within 2nd Year
8
Surgery
Group
Value
95% CI
Baseline
7
Within 1st Year
37
Within 2nd Year
17
Number of Participants Based on Tumor Severity Classification at Baseline Based on MRI in Patients With Diffuse TGCT (d-TGCT)Primary· at Baseline
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).
Moderate diffuse
Group
Value
95% CI
Tenosynovial Giant Cell Tumors
66
Severe diffuse
Group
Value
95% CI
Tenosynovial Giant Cell Tumors
90
Not assessable
Group
Value
95% CI
Tenosynovial Giant Cell Tumors
20
Number of Cases With Complications Due to Surgery in Patients With Diffuse TGCT (d-TGCT)Primary· at Baseline (prior to any d-TGCT therapy)
Complications due to surgery were collected from information routinely recorded in the patient files / medical records.
Group
Value
95% CI
Tenosynovial Giant Cell Tumors
9
Number of Participants With Tumor Recurrence at Baseline in Patients With Diffuse TGCT (d-TGCT)Primary· at Baseline
Tumor recurrence was collected from information routinely recorded in the patient files / medical records.
1 recurrence
Group
Value
95% CI
Participants With Tumor Recurrence
40
2 recurrences
Group
Value
95% CI
Participants With Tumor Recurrence
18
3 recurrences and more
Group
Value
95% CI
Participants With Tumor Recurrence
19
Missing
Group
Value
95% CI
Participants With Tumor Recurrence
1
Time Since Most Recent Tumor Recurrence Until Baseline in Patients With Diffuse TGCT (d-TGCT)Primary· at Baseline
Time since most recent tumor recurrence was collected from information routinely recorded in the patient files / medical records.
Group
Value
95% CI
Tenosynovial Giant Cell Tumors
12.55
0.03 – 137.49
Time From Baseline to First Tumor Recurrence in Patients With Diffuse TGCT (d-TGCT)Primary· Baseline up to end of observation period (approximately 2 years)
Time from baseline to first tumor recurrence was collected from information routinely recorded in the patient files / medical records.
Group
Value
95% CI
Within 1st Year
8.4
2 – 15
Within 2nd Year
19.0
12 – 24
Tenosynovial Giant Cell Tumors
14.8
2 – 24
Mean Brief Pain Inventory (BPI) Pain Severity and Interference Score From Baseline Through 24 MonthsPrimary· Baseline up to end of observation period (approximately 2 years)
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.
Brief Pain Inventory Pain Severity
Group
Value
95% CI
Baseline
3.35
± 2.36
6 Months
3.12
± 2.26
12 Months
3.15
± 2.22
18 Months
3.05
± 2.30
24 Months
2.60
± 2.19
Brief Pain Inventory Pain Interference
Group
Value
95% CI
Baseline
2.97
± 2.65
6 Months
2.94
± 2.56
12 Months
2.80
± 2.44
18 Months
2.80
± 2.47
24 Months
2.53
± 2.57
Mean Worst Stiffness Score From Baseline Through 24 MonthsPrimary· Baseline up to end of observation period (approximately 2 years)
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.
Group
Value
95% CI
Baseline
4.4
± 2.8
6 Months
4.2
± 2.6
12 Months
4.2
± 2.8
18 Months
4.2
± 2.7
24 Months
3.9
± 2.7
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07474649 — A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
· Phase 3
· not yet recruiting
NCT07206472 — A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholestero
· active not recruiting
NCT07220616 — A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies
· Phase 1, PHASE2
· recruiting
NCT07268625 — Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorv
· Phase 1
· completed
NCT07244341 — A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (
· Phase 1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Daiichi Sankyo
Last refreshed: 31 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02948088.