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

Not yet recruiting

• Conditions: Myelodysplastic Syndromes; Myelodysplastic Syndrome/Neoplasm; Acute Myeloid Leukemia
• Interventions: Diagnostic Test: Flow cytometry

• Registration Number: NCT04517175
• Lead Sponsor: Maastricht University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-14
• Last Update Submitted: 2020-08-14
• Study First Posted: 2020-08-18
• Last Update Posted: 2020-08-18
• Study Start: 2020-09-01
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• MDS and AML patients

Exclusion Criteria

• Ongoing radio- and/or chemotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute myeloid Leukemia (AML) patients	Flow cytometry	AML patients will be divided according to prognostic parameters in sub-cohorts.
Myelodysplastic syndrome/neoplasm (MDS/MPN) patients	Flow cytometry	MDS/MPN patients will be divided according to prognostic parameters in sub-cohorts.
Myelodysplastic syndrome (MDS) patients	Flow cytometry	MDS patients will be divided according to prognostic parameters in sub-cohorts.

Primary Outcome Measures

Name	Time	Method
Maturation patterns diagnosis	5 years	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.
Proliferative index diagnosis	5 years	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.
Proliferative index prognosis	5 years	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.