A Prospective, Non-Interventional, Post-Marketing Observational Study Evaluating the Effectiveness and Safety of Selpercatinib Capsules in Adults and Pediatric Patients with Advanced or Metastatic RET Fusion-Positive Thyroid Cancer

Study identification

• EU PAS number:
  EUPAS105321
• Study ID:
  105322
• Official title and acronym:
  A Prospective, Non-Interventional, Post-Marketing Observational Study Evaluating the Effectiveness and Safety of Selpercatinib Capsules in Adults and Pediatric Patients with Advanced or Metastatic RET Fusion-Positive Thyroid Cancer
• DARWIN EU® study:
  No
• Study countries:
  China
• Study status:
  Planned

Research institutions and networks

Institutions

Peking Union Medical College Hospital

- Union Hospital, Tongji Medical College, University of Science and Technology, Wuhan
- Zhejiang Cancer Hospital, Hangzhou
- Shanghai Tenth People's Hospital
- The Affiliated Hospital of Xuzhou Medical University

Study timelines

Date when funding contract was signed

Planned: 27/10/2022

Actual: 27/10/2022

Study start date

Planned: 03/01/2024

Data analysis start date

Planned: 30/01/2026

Date of final study report

Planned: 30/04/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly

Regulatory

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