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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04517175
• Other study ID #: 2019-1345
• Status: Not yet recruiting
• Start date: September 1, 2020
• Est. completion date: September 1, 2025

Study information

• Verified date: August 2020
• Source: Maastricht University
• Contact: Mathie Leers, Dr.
• Phone: +31 45 5767503
• Email: mat.leers[@]zuyderland.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• MDS and AML patients

Exclusion Criteria:

• Ongoing radio- and/or chemotherapy

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome/Neoplasm
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Diagnostic Test:
• Flow cytometry
Flow cytometric immunophenotyping and determination of proliferative activity by means of Ki-67.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University	Maastricht University Medical Center, Zuyderland Medisch Centrum

References & Publications (1)

Nies KPH, Kraaijvanger R, Lindelauf KHK, Drent RJMR, Rutten RMJ, Ramaekers FCS, Leers MPG. Determination of the proliferative fractions in differentiating hematopoietic cell lineages of normal bone marrow. Cytometry A. 2018 Nov;93(11):1097-1105. doi: 10.1002/cyto.a.23564. Epub 2018 Sep 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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