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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04676945

Enrollment

9179

Registered

2020-12-21

Start date

2020-08-21

Completion date

2022-11-21

Last updated

2022-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndromes

Keywords

MDS, IPSS-R

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
1.Overall Survival	From date of diagnosis until the date of death or lost to follow-up, whichever came first. No administrative censoring will be applied to the retrospectively collected data, a minimum period of two months of stable disease will be required.	In \overall survival\ two possible events are defined: * \death\ (regarded as complete observation) * \end of follow up\ (regarded as censored observation) Time is calculated from diagnosis to the first occurrence of one of the above listed events.
2.Time to transformation	From date of diagnosis until the date of transformation,death or lost to follow-up, whichever came first. No administrative censoring will be applied to the retrospectively collected data,a minimum period of two months of stable disease will be required.	In \time to transformation\ three possible events are defined: * \transformation into AML\ (regarded as complete observation) * \death without transformation\ (regarded as censored observation) * \end of follow up\ (regarded as censored observation) Time is calculated from diagnosis to the first occurrence of one of the above listed events. In case of \transformation into AML\ this results in a complete observation, in case of \death without transformation\ or \end of follow up\ the observation is treated as censored.

Countries

Austria

Outcome results