Status:
COMPLETED
Observational Study Towards the Impact of Newly Started Treatment in MDS on QoL
Lead Sponsor:
University Hospital, Antwerp
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Brief Summary
Study type An observational study conducted in different hematological centers in Belgium. Study objectives Primary objective: To assess the impact of newly started treatments on the QOL of patient...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Newly diagnosed patients with myelodysplastic syndromes defined by WHO 2016 criteria that are about to start treatment.
- Patients with a known diagnosis of MDS, irrespective of IPSS and irrespective of time of diagnosis that are about to start a new therapy.
- Signed informed consent
- Exclusion criteria
- Patients with acute leukemia defined as \>20% bone marrow blasts.
- Patients suffering from a myelodysplastic/myeloproliferative overlap syndrome. In this case the disease has both dysplastic and proliferative features but cannot be properly categorized to either group. This category includes chronic myelomonocytic leukemia (CMML), juvenile myelomonocytic leukemia (JMML), atypial chronic myeloid leukemia (aCML) and myelodysplastic/myeloproliferative disease unclassifiable.
- Patients in post allogeneic transplant setting.
- Patients enrolled in a blinded interventional therapeutic trial.
- Patients starting with multiple MDS treatments at the same moment apart from intensive chemotherapy.
- Newly diagnosed patients who do not start with treatment.
- Patients who started a previous MDS related treatment less then 4 weeks ago.
- Patients who started a previous MDS related treatment less then 12 weeks ago apart from packed cell transfusions.
- Diagnosis of any previous or concomitant malignancy except when the patient successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 3 months prior to inclusion.
- Patients refusing to sign informed consent
Exclusion
Key Trial Info
Start Date :
August 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04053933
Start Date
August 1 2019
End Date
July 31 2021
Last Update
March 30 2025
Active Locations (21)
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1
Imelda
Bonheiden, Antwerpen, Belgium, 2820
2
AZ KLINA
Brasschaat, Antwerpen, Belgium, 2930
3
Sint-Dimpna Ziekenhuis Geel
Geel, Antwerpen, Belgium, 2240
4
Heilig Hart Ziekenhuis
Lier, Antwerpen, Belgium, 2500