Myelodysplastic SyndromesNCT04517175
Could Ki-67 be Used as a Diagnostic or Prognostic Marker in Hemato-oncological Diagnostics?
An observational study of Myelodysplastic Syndromes and Acute Myeloid Leukemia, run by Maastricht University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Acute Myeloid Leukemia, Myelodysplastic Syndrome/Neoplasm
- What is being tested?
- Flow cytometry
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- MDS and AML patients
Who cannot join
- Ongoing radio- and/or chemotherapy
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Being tested
- Flow cytometry
- Keywords
- Ki-67
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow cytometryDiagnostic test
Flow cytometric immunophenotyping and determination of proliferative activity by means of Ki-67.
| Study group | Role | What they receive |
|---|---|---|
| Myelodysplastic syndrome (MDS) patients | MDS patients will be divided according to prognostic parameters in sub-cohorts. Receives: Diagnostic Test: Flow cytometry | |
| Acute myeloid Leukemia (AML) patients | AML patients will be divided according to prognostic parameters in sub-cohorts. Receives: Diagnostic Test: Flow cytometry | |
| Myelodysplastic syndrome/neoplasm (MDS/MPN) patients | MDS/MPN patients will be divided according to prognostic parameters in sub-cohorts. Receives: Diagnostic Test: Flow cytometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Zuyderland Medisch Centrum, Maastricht University Medical Center
- Responsible party
- Principal investigator, Stefan Mestrum, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517175
- Sponsor's protocol ID
- 2019-1345
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30176186
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Ki-67 be Used as a Diagnostic or Prognostic Marker in Hemato-oncological Diagnostics?
- ClinicalTrials.gov ID
- NCT04517175
- Acronym / sponsor ID
- 2019-1345
- Keywords
- Ki-67
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Zuyderland Medisch Centrum, Maastricht University Medical Center
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Myelodysplastic syndrome (MDS) patients | – | Diagnostic Test: Flow cytometryMDS patients will be divided according to prognostic parameters in sub-cohorts. |
| Acute myeloid Leukemia (AML) patients | – | Diagnostic Test: Flow cytometryAML patients will be divided according to prognostic parameters in sub-cohorts. |
| Myelodysplastic syndrome/neoplasm (MDS/MPN) patients | – | Diagnostic Test: Flow cytometryMDS/MPN patients will be divided according to prognostic parameters in sub-cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- MDS and AML patients
Key exclusion criteria (1 listed)
- Ongoing radio- and/or chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow cytometryFlow cytometric immunophenotyping and determination of proliferative activity by means of Ki-67. | Diagnostic test | Acute myeloid Leukemia (AML) patients, Myelodysplastic syndrome (MDS) patients, Myelodysplastic syndrome/neoplasm (MDS/MPN) patients |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Background: PubMed 30176186Nies 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes and Acute Myeloid Leukemia, run by Maastricht University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathie Leers, Dr. (+31 45 5767503, mat.leers@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maturation patterns diagnosis (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04517175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.