Analysis of Risk in MDS Over Time - Comparison of Treated vs Untreated Patients

Michael Pfeilstöcker

Status: Completed

Conditions: Myelodysplastic Syndromes

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04676945

N/A-NI-MDSAML-PI-14023

Details and patient eligibility

About

A comparison of treated vs untreated patients with MDS with a sample size of approximately 8000 patients in 11 countries.

Full description

Non-interventional multicentre retrospective study using chart reviews - study was submitted to the ethics committee of city of Vienna - due to the design of the study no specific approval necessary.

Inclusion of MDS (all subtypes and risk groups) patients according to WHO or oligoblastic AML (RAEB-T according to FAB), untreated and treated during their chronic MDS phase

The 26 centers of the IWG-PM have provided control data set of untreated, all centers will be asked for contribution of treated patients Data will be collected in Austria, Brazil, Czech Republic, France, Germany, Italy, Japan, Netherlands, Spain, UK, USA.

Enrollment: 9,179 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• MDS (all subtypes and risk groups) according to WHO or oligoblastic AML (RAEB-T according to FAB) patients untreated and treated during their chronic MDS phase

Exclusion criteria

• None

Trial design

9,179 participants in 2 patient groups

untreated control group

Description:

NO MDS disease modifying therapy

treated patients

Description:

ANY MDS disease modifying therapy