Status: Ongoing First registered on: 28/02/2020
Last updated on: 02/03/2020
1. Study identification
EU PAS Register NumberEUPAS33865
Official titleA Real World Evidence prospective cohort study in the management of metastatic colorectal cancer: a clinical and patient perspective
Study title acronymPROMETCO
Study typeObservational study
Brief description of the studyThis is an observationnal 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
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableClinicalTrials.gov Identifier: NCT03935763 https://clinicaltrials.gov/ct2/show/NCT03935763?term=PROMETCO&draw=2&rank=1
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUMCU
Department/Research group
Organisation/affiliationUniversity Medical Center Utrecht
Website/Homepagewww.umcutrecht.nl
Details of (Primary) lead investigator
Title Professor
Last name Koopman
First name Miriam
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?110
Countries in which this study is being conducted
International study

Argentina
Austria
Belgium
Croatia
Czechia
France
Germany
Greece
Hungary
Ireland
Italy
Netherlands
Portugal
Slovenia
Spain
Sweden
Switzerland
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed23/07/2018
Start date of data collection08/03/2019
Start date of data analysis
Date of interim report, if expected
Date of final study report31/03/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesServier100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Vermeire
First name Alice
Address line 135 rue de Verdun
Address line 2 
Address line 3 
CitySuresnes 
Postcode 
CountryFrance
Phone number (incl. country code)33683996915 
Alternative phone number 
Fax number (incl. country code) 
Email address alice.vermeire@servier.com
Public Enquiries
Title Ms 
Last name Vermeire 
First name Alice 
Address line 135 rue de Verdun 
Address line 2 
Address line 3 
CitySuresnes 
Postcode 
CountryFrance 
Phone number (incl. country code)33683996915 
Alternative phone number 
Fax number (incl. country code) 
Email address alice.vermeire@servier.com 
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