Prospective Observational Non-interventional Study to Describe Characteristics and Management of Patients With Giant Cell Tumor of Bone Treated With XGEVA and Its Use in Routine Clinical Practice in France (20150360)

Study identification

• EU PAS number:
  EUPAS21542
• Study ID:
  22265
• Official title and acronym:
  Prospective Observational Non-interventional Study to Describe Characteristics and Management of Patients With Giant Cell Tumor of Bone Treated With XGEVA and Its Use in Routine Clinical Practice in France (20150360)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The French Health Authorities requested, in July 2015, a study with the objective to « provide long-term data on patients with giant cell tumor of bone treated with XGEVA”. ; This study should be able to provide real world data on the characteristics of treated patients, the conditions of use of XGEVA, the XGEVA impact on morbidity and the Health related quality of life of the patients. ; This study is a prospective observational study.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Networks

ReSos, National network specialized in pathology and care of bone sarcomas

Study timelines

Date when funding contract was signed

Actual: 06/04/2017

Study start date

Planned: 01/01/2018

Actual: 01/01/2018

Data analysis start date

Planned: 15/03/2025

Actual: 04/04/2025

Date of interim report, if expected

Planned: 15/07/2021

Date of final study report

Planned: 04/08/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable