Prospective and retrospective data collection on diagnosis, treatment and course of disease of myelodysplastic syndromes in adults

Prospective and retrospective data collection on diagnosis, treatment and course of disease of myelodysplastic syndromes in adults - MDS Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035198

Enrollment

1200

Registered

2024-10-02

Start date

2022-10-31

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

D46

Interventions

Group 1: Due to the non-interventional nature of the MDS Registry, there are no predefined visits. The frequency of visits and the selection of check-ups are the sole responsibility of the participati

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: written informed consent

Exclusion criteria

Exclusion criteria: Availability of follow-up

Design outcomes

Primary

Measure	Time frame
Evaluation of overall survival in terms of: • MDS-specific factors (u.a. IPSS-R, molecular genetics) • individual factors (HCT-CI, MDS-CI, G8, EQ5D, QUALMS-1, QoL-E, EORTC-QLQ-C30) • therapeutic interventions as compared to only best supportive care	—

Secondary

Measure	Time frame
• Correlation between guideline adherence with Overall and progression-free survival, Improving quality of life • Proportion of MDS patients treated according to guidelines • Time from initial MDS diagnosis to first therapeutic intervention • Systematic quantitative assessment of transfusion burden and validation of newly proposed IWG criteria • Correlation of course of treatment, remission rate and duration, depth of response in MDS-subtypes to the different treatments • Assessment of reason and duration of hospitalization during the course of disease • Occurrence of Serious Adverse Events related to treatment • Proportion of patients and characerization of patients who entered into clinical trials • Correlation of chromosomal findings and somatic mutations with response to treatment • Correlation between diagnostic procedures including cytomorphology, histomorphology and flow cytometry • Characterization of MDS patients receiving allogeneic stem cell transplantation and their outcome • Comparison of overall survival and AML transformation between historical and current patient cohorts of the MDS Registry from 1982-1992, 1993-2002, 2003-2013, 2014-2021 • Validation of the proposals of the IPSS-R group for a molecular IPSS-R • Validation of WHO proposals for the classification of therapyrelated myeloid neoplasms • Validation of WHO proposals for the classification of AML-MRC • Validation of prognostic scoring systems for patients undergoing different treatment strategies • Assessment of clonal evolution during the course of disease and treatment (banding cytogentics and variant allele frequency of somatic mutations) and their impact on outcome • Characterization of MDS-associated diseases like ICUS; CHIP and CHOP and assessment of progress and treatment • Assessment of clinically relevant events in patients with significant thrombocytopenia • Correlation of hemoglobin during the course w	—

Measure

Time frame

• Correlation between guideline adherence with Overall and progression-free survival, Improving quality of life • Proportion of MDS patients treated according to guidelines • Time from initial MDS diagnosis to first therapeutic intervention • Systematic quantitative assessment of transfusion burden and validation of newly proposed IWG criteria • Correlation of course of treatment, remission rate and duration, depth of response in MDS-subtypes to the different treatments • Assessment of reason and duration of hospitalization during the course of disease • Occurrence of Serious Adverse Events related to treatment • Proportion of patients and characerization of patients who entered into clinical trials • Correlation of chromosomal findings and somatic mutations with response to treatment • Correlation between diagnostic procedures including cytomorphology, histomorphology and flow cytometry • Characterization of MDS patients receiving allogeneic stem cell transplantation and their outcome • Comparison of overall survival and AML transformation between historical and current patient cohorts of the MDS Registry from 1982-1992, 1993-2002, 2003-2013, 2014-2021 • Validation of the proposals of the IPSS-R group for a molecular IPSS-R • Validation of WHO proposals for the classification of therapyrelated myeloid neoplasms • Validation of WHO proposals for the classification of AML-MRC • Validation of prognostic scoring systems for patients undergoing different treatment strategies • Assessment of clonal evolution during the course of disease and treatment (banding cytogentics and variant allele frequency of somatic mutations) and their impact on outcome • Characterization of MDS-associated diseases like ICUS; CHIP and CHOP and assessment of progress and treatment • Assessment of clinically relevant events in patients with significant thrombocytopenia • Correlation of hemoglobin during the course w

—

Countries

Germany

Contacts

Public ContactU. Germing

Universitätsklinik Düsseldorf

germing@med.uni-duesseldorf.de211-81-17780

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026