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

NCT04517175 | Unknown

• 1 other identifier: 2019-1345
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myelodysplastic Syndromes; Acute Myeloid Leukemia; Myelodysplastic Syndrome/Neoplasm

Keywords

Ki-67

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Myelodysplastic syndrome (MDS) patients

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

Diagnostic Test: Flow cytometry

Acute myeloid Leukemia (AML) patients

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

Diagnostic Test: Flow cytometry

Myelodysplastic syndrome/neoplasm (MDS/MPN) patients

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

Diagnostic Test: Flow cytometry

Interventions

Flow cytometry DIAGNOSTIC_TEST

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

Acute myeloid Leukemia (AML) patients; Myelodysplastic syndrome (MDS) patients; Myelodysplastic syndrome/neoplasm (MDS/MPN) patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in which a hemato-oncological malignancy is found and are at least 18 years old. These patients can be male and female.

You may qualify if:

• MDS and AML patients

You may not qualify if:

• Ongoing radio- and/or chemotherapy

Sponsors & Collaborators

• Maastricht University: lead
• Zuyderland Medisch Centrum: collaborator
• Maastricht University Medical Center: collaborator

Related 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.

  PMID: 30176186 BACKGROUND

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Anemia, Refractory, with Excess of Blasts

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Anemia, Refractory; Anemia

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Mathie Leers, Dr.

CONTACT

+31 45 5767503; mat.leers@zuyderland.nl

Bart de Wit, Dr.

CONTACT

+31 43 3874694; b.de.wit@mumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 18, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 18, 2020

Record last verified: 2020-08