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

NCT ID: NCT04517175

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Myelodysplastic Syndromes Acute Myeloid Leukemia Myelodysplastic Syndrome/Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Myelodysplastic syndrome (MDS) patients

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

Flow cytometry

Intervention Type DIAGNOSTIC_TEST

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.

Flow cytometry

Intervention Type DIAGNOSTIC_TEST

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.

Flow cytometry

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Flow cytometry

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* MDS and AML patients

Exclusion Criteria

* Ongoing radio- and/or chemotherapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zuyderland Medisch Centrum

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role collaborator

Maastricht University

OTHER

Sponsor Role lead

Responsible Party

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Stefan Mestrum

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mathie Leers, Dr.

Role: CONTACT

+31 45 5767503

Bart de Wit, Dr.

Role: CONTACT

+31 43 3874694

References

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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.

Reference Type BACKGROUND
PMID: 30176186 (View on PubMed)

Other Identifiers

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2019-1345

Identifier Type: -

Identifier Source: org_study_id

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