An observational study in Myelodysplastic Syndromes, Acute Myeloid Leukemia and Myelodysplastic Syndrome/Neoplasm, sponsored by Maastricht University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-18.
Sponsored by Maastricht University · Observational
Ki-67 is used as a marker for determination of the proliferative activity in solid tumors. The use within hemato-oncological malignancies is limited. This is related to limited technical possibilities of flow cytometry in the past. Meanwhile, flow cytometry in hemato-oncological malignancies has progressed to assessment of 8 colors and makes it possible to add Ki-67 as an additional marker to the 8-color panels. Adding Ki-67 to these panels could lead to improved diagnosis and prediction of therapy response for a number of hemato-oncological malignancies.
1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.
This study's planned enrollment of 300 is above the median of 114 across 116 observational studies indexed under Preleukemia.
Browse Preleukemia studies →Maastricht University is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients in which a hemato-oncological malignancy is found and are at least 18 years old. These patients can be male and female.
Exclusion Criteria:
MDS patients will be divided according to prognostic parameters in sub-cohorts.
Diagnostic Test: Flow cytometry
AML patients will be divided according to prognostic parameters in sub-cohorts.
Diagnostic Test: Flow cytometry
MDS/MPN patients will be divided according to prognostic parameters in sub-cohorts.
Diagnostic Test: Flow cytometry
Flow cytometric immunophenotyping and determination of proliferative activity by means of Ki-67.
Maturation patterns diagnosis
Maturation patterns based on immunophenotype for red blood cells and several types of immune cells and their respective contributions to diagnosis. Maturation patterns are scored by various methods/combinations to form diagnostic score. A higher diagnostic score will lead to a more likely diagnose for MDS and/or AML.
Time frame: 5 years
Proliferative index diagnosis
Ki-67 proliferative index (within populations and maturation) and its contribution to diagnosis. A lower Ki-67 proliferative index will lead to a more likely diagnose for MDS and/or AML.
Time frame: 5 years
Proliferative index prognosis
Ki-67 as prognostic parameter. A lower Ki-67 proliferative index will (hypothetically) lead to worse prognosis for MDS and AML in terms of: transfusion dependence (expressed in amount of transfusions in 2 months), chemotherapy response (expressed as total remission, normalization of blood values, possibly also normalization of cytogenetics in bone marrow cells), overall survival (expressed in months after diagnosis), Risk scores. Higher risk scores are correlated with worse prognosis.
Time frame: 5 years
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Maastricht University