A Real World Evidence prospective cohort study in the management of metastatic colorectal cancer: a clinical and patient perspective (PROMETCO)

Study identification

• EU PAS number:
  EUPAS33865
• Study ID:
  40302
• Official title and acronym:
  A Real World Evidence prospective cohort study in the management of metastatic colorectal cancer: a clinical and patient perspective (PROMETCO)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Austria

  Belgium

  Croatia

  Czechia

  France

  Germany

  Greece

  Hungary

  Ireland

  Italy

  Netherlands

  Portugal

  Slovenia

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  This is an observational study to describe the following for mCRC patients in a real world setting:; - Overall survival ; - Treatment patterns for mCRC throughout the continuum of care Effectiveness/safety of treatments ; - Reasons for therapy discontinuations and choice of subsequent treatment ; - Adherence to National and European Society for Medical Oncology (ESMO) Guidelines ; - Healthcare resource utilization ; - Patient reported outcomes
• Study status:
  Finalised

Research institutions and networks

Institutions

University Medical Center Utrecht (UMCU)

Netherlands

Study timelines

Date when funding contract was signed

Actual: 23/07/2018

Study start date

Actual: 08/03/2019

Date of final study report

Planned: 30/09/2024

Actual: 21/11/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Servier

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

ClinicalTrials.gov Identifier: NCT03935763,https://clinicaltrials.gov/ct2/show/NCT03935763?term=PROMETCO&draw=2&rank=1