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

August 14, 2020 updated by: Stefan Mestrum, Maastricht University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • MDS and AML patients

Exclusion Criteria:

  • Ongoing radio- and/or chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Myelodysplastic syndrome (MDS) patients
MDS patients will be divided according to prognostic parameters in sub-cohorts.
Diagnostic test: Flow cytometry
Flow cytometric immunophenotyping and determination of proliferative activity by means of Ki-67.
Acute myeloid Leukemia (AML) patients
AML patients will be divided according to prognostic parameters in sub-cohorts.
Diagnostic test: Flow cytometry
Flow cytometric immunophenotyping and determination of proliferative activity by means of Ki-67.
Myelodysplastic syndrome/neoplasm (MDS/MPN) patients
MDS/MPN patients will be divided according to prognostic parameters in sub-cohorts.
Diagnostic test: Flow cytometry
Flow cytometric immunophenotyping and determination of proliferative activity by means of Ki-67.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maturation patterns diagnosis
Time Frame: 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.
5 years
Proliferative index diagnosis
Time Frame: 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.
5 years
Proliferative index prognosis
Time Frame: 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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University

Collaborators

Maastricht University Medical Center
Zuyderland Medisch Centrum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

September 1, 2025

Study Completion (Anticipated)

September 1, 2025

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 14, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 14, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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