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

Radboud University Medical Center

Status

Unknown

Conditions

Myelodysplastic Syndromes (MDS)

Treatments

Other: No interventions

Study type

Observational

Funder types

Other

Identifiers

NCT00600860

883

Details and patient eligibility

About

Study Objectives:

To collect and describe demographics, disease-management, and treatment outcomes of Myelodysplastic Syndromes (MDS) patients who are newly diagnosed and classified according to the World Health Organization (WHO) criteria.

To perform observational studies concerning relevant scientific research questions in MDS using clinical data and biological samples, and to present relevant research outcomes in the fields of diagnosis and prognostication, health related quality of life issues, health economics, and risk stratification for newly developed classes of drugs.

To disseminate results of the studies to all stakeholders involved.

Full description

Methodology:

Data on patients with MDS will be collected prospectively at diagnosis and at 6-months intervals after diagnosis. The data will be gathered by seventeen (or more) countries that are represented within the LeukemiaNet MDS Working Party and will be combined in one central European Database. Data analyses will be conducted by the Data Management Centre at the University of York in various sub studies, at specific time points as decided or requested by the steering committee, but at least once a year included in the European Registry and at the end of the follow-up period.

Number of Patients & Centres Over 149 hematology centres in eighteen (or more) different countries (Austria, Croatia, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, The Netherlands, Romania, Spain, Sweden, Switzerland and United Kingdom) will participate as referral centres in this Registry. The recruitment target is a minimum of 3000 cases lower-risk MDS and 1000 higher-risk cases.

Population:

The study population will consist of newly diagnosed patients with all subtypes of MDS classified according to the WHO criteria, including therapy-related MDS and MDS-F, AML with 20-<30 percent marrow blasts (former RAEB-t), and CMML and other forms of mixed MDS/MPD.

Study Duration:

The enrolment time is scheduled to continue until at least December 2022 but extension of the recruitment period is possible. Patients will be followed until withdrawal (for any reason) or termination of the EUMDS Registry.

Enrollment

4,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 bone marrow (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