Could Ki-67 be Used as a Diagnostic or Prognostic Marker in Hemato-oncological Diagnostics?

Study Overview
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Brief Summary
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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.

Official Title
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Could Ki-67 be Used as a Diagnostic or Prognostic Marker in Hemato-oncological Diagnostics?

Conditions
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Myelodysplastic Syndromes, Acute Myeloid Leukemia, Myelodysplastic Syndrome/Neoplasm

Intervention / Treatment
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* Diagnostic Test: Flow cytometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MDS and AML patients Exclusion Criteria: Ongoing radio- and/or chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Myelodysplastic syndrome (MDS) patients<br>MDS patients will be divided according to prognostic parameters in sub-cohorts. | Diagnostic Test: Flow cytometry<br>* Flow cytometric immunophenotyping and determination of proliferative activity by means of Ki-67.<br>|
| Acute myeloid Leukemia (AML) patients<br>AML patients will be divided according to prognostic parameters in sub-cohorts. | Diagnostic Test: Flow cytometry<br>* Flow cytometric immunophenotyping and determination of proliferative activity by means of Ki-67.<br>|
| Myelodysplastic syndrome/neoplasm (MDS/MPN) patients<br>MDS/MPN patients will be divided according to prognostic parameters in sub-cohorts. | Diagnostic Test: Flow cytometry<br>* Flow cytometric immunophenotyping and determination of proliferative activity by means of Ki-67.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ki-67