Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib

Study Purpose

The goal of this observational study is to better understand real-world use of vimseltinib, treatment patterns, and health-related quality of life in participants treated with vimseltinib for TGCT. This study will collect data in an observational disease registry involving no intervention to the participants and will not influence standard medical care or impact treatment decisions for participants.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Diagnosis of TGCT according to medical records. 2. Prescribed vimseltinib per the approved label requirements. Participants are eligible if either (A) the decision to receive vimseltinib has been made but treatment has not yet been initiated or (B) the decision to receive vimseltinib has been made and participant has received first dose of prescribed vimseltinib less than 6 months prior to study enrollment. 3. Has provided informed consent and medical records release.

Exclusion Criteria:

1. Participant has received any other systemic agent for the treatment of TGCT during the 6 months prior to starting treatment with vimseltinib. 2. Participant has received the first dose of prescribed vimseltinib in the current treatment course more than 6 months before study enrollment. 3. Participant is active in an interventional clinical trial of vimseltinib

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07075471
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Deciphera Pharmaceuticals, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Team
Principal Investigator Affiliation Deciphera Pharmaceuticals, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Tenosynovial Giant Cell Tumor

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Synexus Clinical Research, US INC, Wilmington, North Carolina

Status

Recruiting

Address

Synexus Clinical Research, US INC

Wilmington, North Carolina, 28401