CompletedNot Applicable

Tenosynovial Giant Cell Tumors (TGCT) Observational Platform Project

United States, Austria, France183 participantsStarted 2016-11-18

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

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)

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)

Number of Participants Based on Status of Treatment Plan in Patients With Diffuse TGCT (d-TGCT)

Timeframe: 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)

Timeframe: 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)

Timeframe: at Baseline

Trial details

NCT IDNCT02948088

SponsorDaiichi Sankyo

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-03-11

Results submitted2021-12-21

View on ClinicalTrials.gov More Giant Cell Tumors trials