A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00600860
• Date of registration: 14/01/2008
• Prospective Registration: Yes
• Primary sponsor: Radboud University
• Public title: A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes EUMDS
• Scientific title: A Prospective, Multicentre European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes (MDS), Including Acute Myeloid Leukaemia With 20-30 Percent Marrow Blasts (Former RAEB-t), and Chronic Myelomonocytic Leukaemia (CMML)
• Date of first enrolment: April 2008
• Target sample size: 4000
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT00600860
• Study type: Observational

Countries of recruitment

Austria, Croatia, Czech Republic, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Spain, Sweden, Switzerland, United Kingdom

Contacts

• Name: Theo de Witte, Prof Dr
• Affiliation: Radboud University

• Name: Corine J van Marrewijk, PhD

• Name: David Bowen, PhD
• Affiliation: Leeds General Infirmary

Key inclusion & exclusion criteria

Inclusion Criteria:

Patients must meet all of the following criteria

- Age > 18 years

- Newly diagnosed patient (within 100 days from the date of the diagnostic BM aspirate)

- MDS classified according to current WHO criteria

- All sub groups of MDS

- Therapy-related MDS

- MDS with Fibrosis (MDS-F)

- AML with 20-30 percent marrow blasts (former RAEB-t)

- CMML and other forms of mixed MDS/MPD

- IPSS and IPSS-R Risk group classification (mandatory)

- Able and willing to provide the written informed consent

Exclusion Criteria:

- Age <18 years

- Patient unwilling or unable to give consent

- AML with =30 percent marrow blasts according to WHO

- Patients with inv(16), t(5;17) and t(8;21) are considered AML and therefore not
eligible

- Patients with higher risk MDS progressed from a previously diagnosed lower risk MDS
that was not registered within 100 days after first diagnosis of (lower risk) MDS



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Myelodysplastic Syndromes (MDS)

Intervention(s)

Other: No interventions

Primary Outcome(s)

Demographics [Time Frame: 12 years of FU]

Secondary Outcome(s)

Correlations [Time Frame: 12 years of FU]

Scientific research in MDS [Time Frame: 12 years of FU]

New prognostic scoring systems [Time Frame: 12 years of FU]

Secondary ID(s)

883

Source(s) of Monetary Support

Please refer to primary and secondary sponsors