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OpenTrials
Completed

NCT Number: NCT04676945

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

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

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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanusch Krankenhaus, 3.Medizinische Abteilung

Vienna, 1140, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 1.Overall Survival

    Time frame: 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. 2.Time to transformation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Michael Pfeilstöcker

Other

Collaborators

  • Celgene Corporation

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 21, 2020
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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