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

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

Detailed Description
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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.

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

Conditions
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Myelodysplastic Syndromes

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| untreated control group<br>NO MDS disease modifying therapy | |
| treated patients<br>ANY MDS disease modifying therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.Overall Survival | 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. | 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. | 
| 2.Time to transformation | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDS, IPSS-R