Non-interventional cohort registry study to assess characteristics and management of patients with Merkel Cell Carcinoma in Germany (MCC-TRIM)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34181
• EU PAS number:
  EUPAS25338
• Study ID:
  34181
• Official title and acronym:
  Non-interventional cohort registry study to assess characteristics and management of patients with Merkel Cell Carcinoma in Germany (MCC-TRIM)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This is a 5-year non-interventional (observational), longitudinal, multi-site cohort registry study focusing on various epidemiological and clinical aspects to be assessed in patients diagnosed with MCC in Germany. The design is an open cohort study design, with dynamic, renewed sampling, allowing for each eligible patient to have the same probability to be included throughout the inclusion period.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck Healthcare KGaA

Germany

Study timelines

Date when funding contract was signed

Actual: 21/08/2017

Study start date

Planned: 01/04/2019

Actual: 29/04/2019

Date of final study report

Planned: 31/12/2024

Actual: 27/11/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck KGaA

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)