Medullary Thyroid Carcinoma Surveillance Study: a Case-Series Registry (H9X-MC-B001)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45077
• EU PAS number:
  EUPAS45076
• Study ID:
  45077
• Official title and acronym:
  Medullary Thyroid Carcinoma Surveillance Study: a Case-Series Registry (H9X-MC-B001)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Please refer to EUPAS8759. This study is conducted in the US. The aim of the study is to monitor the number of annual new cases of medullary thyroid carcinoma (MTC) and to establish a registry of incident cases of MTC in adults in order to characterize their medical histories and possible risk factors, including history of treatment with long-acting GLP-1 receptor agonists.
• Study status:
  Ongoing

Research institutions and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Study timelines

Date when funding contract was signed

Actual: 19/01/2015

Study start date

Actual: 19/01/2015

Date of final study report

Planned: 31/12/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company, Novo-Nordisk, AstraZeneca

Study protocol

Initial protocol

MTC Case Series Registry Protocol_v8.0 dated 03Feb2022_Redacted

Updated protocol

MTC Case Series Registry Protocol February 2023_FINAL_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)