Completed

TOPA 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)

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Giant Cell Tumor of Tendon Sheath+9

+ Giant Cell Tumors

+ Joint Diseases

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: November 2016
See protocol details

Summary

Principal SponsorDaiichi Sankyo
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 18, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleA 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)
NCT02948088
Principal SponsorDaiichi Sankyo
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

183 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Giant Cell Tumor of Tendon SheathGiant Cell TumorsJoint DiseasesMuscular DiseasesMusculoskeletal DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms, Connective TissueSynovitisSynovitis, Pigmented VillonodularNeoplasms, Connective and Soft TissueTendinopathy

Criteria

2 inclusion criteria required to participate
Written informed consent for participation in the study (ICF)

Patients with d-TGCT (diagnosed histologically) confirmed naïve or recurrent case

1 exclusion criteria prevent from participating
As this is a non interventional study, no explicit exclusion criteria have been defined

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 15 locations

Suspended

David Geffen School of Medicine at UCLA

Los Angeles, United StatesOpen David Geffen School of Medicine at UCLA in Google Maps
Suspended

University of California San Francisco

San Francisco, United States
Suspended

Memorial Sloan Kettering Cancer Center

New York, United States
Suspended

University of Texas MD Anderson Cancer Center

Houston, United States
Completed15 Study Centers