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

Maastricht University

Status: Not yet enrolling

Conditions: Myelodysplastic Syndrome/Neoplasm; Myelodysplastic Syndromes; Acute Myeloid Leukemia

Treatments: Diagnostic Test: Flow cytometry

Study type: Observational

Funder types: Other

Identifiers

NCT04517175

2019-1345

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• MDS and AML patients

Exclusion criteria

• Ongoing radio- and/or chemotherapy

Trial design

300 participants in 3 patient groups

Myelodysplastic syndrome (MDS) patients

Description:

MDS patients will be divided according to prognostic parameters in sub-cohorts.

Treatment:

Diagnostic Test: Flow cytometry

Acute myeloid Leukemia (AML) patients

Description:

AML patients will be divided according to prognostic parameters in sub-cohorts.

Treatment:

Diagnostic Test: Flow cytometry

Myelodysplastic syndrome/neoplasm (MDS/MPN) patients

Description:

MDS/MPN patients will be divided according to prognostic parameters in sub-cohorts.

Treatment:

Diagnostic Test: Flow cytometry