Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT04053933
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04053933
Study Brief:
Protocol Section:
NCT04053933