Status: Finalised
First registered on:
31/01/2023
Last updated on:
28/03/2023
1. Study identification
EU PAS Register NumberEUPAS50800
Official titleDARWIN EU® – Prevalence of rare blood cancers in Europe
Study title acronym
Study typeObservational study
Brief description of the studyIn this study the prevalence of rare blood cancers (follicular lymphoma, diffuse large B-Cell lymphoma, multiple myeloma, chronic lymphocytic leukaemia, acute myeloid leukaemia, acute lymphocytic leukaemia) will be assessed.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameDARWIN EU CC
Centre locationRotterdam, Netherlands
Details of (Primary) lead investigator
Title Mr
Last name Burn
First name Edward
Is this study being carried out with the collaboration of a research network?
Yes
Other centres where this study is being conducted
Multiple centres
In total how many centres are involved in this Study?4
University of Oxford, UK
Countries in which this study is being conducted
International study
Belgium
Germany
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed13/05/202213/05/2022
Start date of data collection01/11/202201/11/2022
Start date of data analysis
Date of interim report, if expected
Date of final study report28/03/202328/03/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding schemeEU funding scheme100
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Burn
First name Edward
Address line 1The Botnar Research Centre
Address line 2Windmill Road
Address line 3Headington
CityOxford
Postcode
CountryUnited Kingdom
Phone number (incl. country code)441865227374
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Mr
Last name Burn
First name Edward
Address line 1The Botnar Research Centre
Address line 2Windmill Road
Address line 3Headington
CityOxford
Postcode
CountryUnited Kingdom
Phone number (incl. country code)441865227374
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Follicular lymphoma
Diffuse large B-cell lymphoma
Multiple myeloma
Chronic lymphocytic leukaemia
Acute myeloid leukaemia
Acute lymphocytic leukaemia
8. Population under study
Age
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects10000000
Additional information
>10,000,000 in the included databases for denominator
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
IQVIA LPD, Belgium
IQVIA DA, Germany
Sources of data
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
To estimate the prevalence of rare blood cancers (follicular lymphoma, diffuse Large B-Cell Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukaemia, Acute Myeloid Leukaemia, Acute Lymphocytic Leukaemia)
Are there primary outcomes?Yes
follicular lymphoma, diffuse Large B-Cell Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukaemia, Acute Myeloid Leukaemia, Acute Lymphocytic
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
5-year partial prevalence will be estimated for each outcome of interest.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
