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

NCT07075471 | Recruiting

• 1 other identifier: DCC-3014-04-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tenosynovial Giant Cell Tumor

Outcome Measures

Primary Outcomes (2)

• Duration of Vimseltinib Treatment

  Baseline up to 12 months

• Time to Discontinuation of Vimseltinib

  Baseline to Discontinuation (Estimated up to 12 months)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants being treated for TGCT with vimseltinib in the community setting.

You may qualify if:

• Diagnosis of TGCT according to medical records
• 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
• Has provided informed consent and medical records release

You may not qualify if:

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

Sponsors & Collaborators

• Deciphera Pharmaceuticals, LLC: lead

Study Sites (1)

Synexus Clinical Research, US INC

Wilmington, North Carolina, 28401, United States

RECRUITING

MeSH Terms

Conditions

Giant Cell Tumor of Tendon Sheath

Condition Hierarchy (Ancestors)

Giant Cell Tumors; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Synovitis; Joint Diseases; Musculoskeletal Diseases; Tendinopathy; Muscular Diseases

Study Officials

• Clinical Team

  Deciphera Pharmaceuticals, LLC

  STUDY DIRECTOR

Central Study Contacts

Clinical Team

CONTACT

888-724-3274; clinicaltrials@deciphera.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 20, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)