Clinical trial · Observational
Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Giant Cell Tumors | Giant Cell Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (13)
- measure
- Number of Participants According to the Management Plan in Patients With Diffuse TGCT (d-TGCT)
- timeFrame
- Baseline up to end of observation period (approximately 2 years)
- description
- The management plan received among the patients was collected from information routinely recorded in the patient files / medical records.
- measure
- Number of Participants According to the Current TGCT Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
- timeFrame
- Baseline up to end of observation period (approximately 2 years)
- description
- The current TGCT treatment plan among the patients was collected from information routinely recorded in the patient files / medical records.
- measure
- Number of Participants Based on Type of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)
- timeFrame
- Baseline up to end of observation period (approximately 2 years)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDPalmerini E, Healey JH, Bernthal NM, Bauer S, Schreuder H, Leithner A, Martin-Broto J, Gouin F, Lopez-Bastida J, Gelderblom H, Staals EL, Mercier F, Laeis P, Ye X, van de Sande M. Tenosynovial Giant Cell Tumor Observational Platform Project (TOPP) Registry: A 2-Year Analysis of Patient-Reported Outcomes and Treatment Strategies. Oncologist. 2023 Jun 2;28(6):e425-e435. doi: 10.1093/oncolo/oyad011. PMID 36869793
- DERIVEDBernthal NM, Spierenburg G, Healey JH, Palmerini E, Bauer S; TOPP Study Group; Gelderblom H, Staals EL, Lopez-Bastida J, Fronk EM, Ye X, Laeis P, van de Sande MAJ. The diffuse-type tenosynovial giant cell tumor (dt-TGCT) patient journey: a prospective multicenter study. Orphanet J Rare Dis. 2021 Apr 29;16(1):191. doi: 10.1186/s13023-021-01820-6. PMID 33926503