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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04517175
Enrollment
300
Registered
2020-08-18
Start date
2020-09-01
Completion date
2025-09-01
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Myelodysplastic Syndrome/Neoplasm, Myelodysplastic Syndromes

Keywords

Ki-67

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.

Interventions

DIAGNOSTIC_TESTFlow cytometry

Flow cytometric immunophenotyping and determination of proliferative activity by means of Ki-67.

Sponsors

Zuyderland Medisch Centrum
CollaboratorOTHER
Maastricht University Medical Center
CollaboratorOTHER
Maastricht University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* MDS and AML patients

Exclusion criteria

* Ongoing radio- and/or chemotherapy

Design outcomes

Primary

MeasureTime frameDescription
Maturation patterns diagnosis5 yearsMaturation 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 diagnosis5 yearsKi-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 prognosis5 yearsKi-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.

Contacts

Primary ContactMathie Leers, Dr.
mat.leers@zuyderland.nl+31 45 5767503
Backup ContactBart de Wit, Dr.
b.de.wit@mumc.nl+31 43 3874694

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026