UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057807 |
|---|---|
| Receipt number | R000066070 |
| Scientific Title | MDS-IPF |
| Date of disclosure of the study information | 2025/05/09 |
| Last modified on | 2025/05/09 08:24:59 |
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Basic information
Public title
Importance of immature platelet fraction as a prognostic factor in myelodysplastic syndromes: a prospective observational study
Acronym
MDS-IPF
Scientific Title
MDS-IPF
Scientific Title:Acronym
MDS-IPF
Region
| Japan |
Condition
Condition
myelodysplastic syndrome
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to verify the usefulness of IPF as a prognostic predictor in MDS patients and to optimize the indications for various treatments.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transition period to acute myeloid leukemia
Key secondary outcomes
Overall survival
Hematological improvement
Changes in transfusion dependency
Correlation between IPF and AZA treatment response
Incidence of adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Newly diagnosed MDS patients
Age: 18 years or older
IPSS-R: All risk groups
IPF measured
Key exclusion criteria
patients with a history of previous treatment for MDS
patients with serious comorbidities
patients for whom it is difficult to obtain consent
Target sample size
97
Research contact person
Name of lead principal investigator
| 1st name | SATOSHI |
| Middle name | |
| Last name | YAMASAKI |
Organization
St.Marry Hospital
Division name
Department of Hematology
Zip code
830-8543
Address
422 Tufukuhonmachi, Kurume, Fukuoka
TEL
0942353322
sa-yamasaki@st-mary-med.or.jp
Public contact
Name of contact person
| 1st name | SATOSHI |
| Middle name | |
| Last name | YAMASAKI |
Organization
St.Marry Hospital
Division name
Department of Hematology
Zip code
830-8543
Address
422 Tufukuhonmachi, Kurume, Fukuoka
TEL
0942353322
Homepage URL
sa-yamasaki@st-mary-med.or.jp
Sponsor or person
Institute
St.Marry Hospital
Institute
Department
Personal name
Funding Source
Organization
St.Marry Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.Marry Hospital
Address
422 Tufukuhonmachi, Kurume, Fukuoka
Tel
0942353322
sa-yamasaki@st-mary-med.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
福岡県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Here is the translated version of the clinical information items to be collected from medical records:
Clinical Information Collected from Medical Records
(For Study Participants)
1. Patient Basic Information
Age
Gender
Details of MDS diagnosis
2. Peripheral Blood Test Data
Complete Blood Count (CBC):
White Blood Cell Count (WBC)
Absolute Neutrophil Count (ANC)
Lymphocyte Percentage
Monocyte Percentage
Blast Percentage
Hemoglobin (Hb)
Mean Corpuscular Volume (MCV)
Platelet Count (Plt)
Reticulocyte Count (IRF)
Immature Platelet Fraction (IPF) Percentage
3. Bone Marrow Examination Data
Bone Marrow Cellularity: High, Normal, Low
Megakaryocyte Evaluation:
Megakaryocyte Count
Presence of Morphological Dysplasia
Lineage Dysplasia:
Erythroid Lineage Dysplasia Presence
Granulocytic Lineage Dysplasia Presence
Blast Percentage
Fibrosis Dysplasia Presence
4. Cell Surface Marker Analysis
CD34-Positive Cell Percentage
5. Genetic/Molecular Testing
Cytogenetic Testing:
MDS IPSS-R Cytogenetic Risk (5-tier classification)
6. Patient-Reported Outcomes (PRO) and Shared Decision-Making (SDM)
Quality of Life (QOL-ACD): Assessed at baseline, 3 months, and 1 year post-treatment
SDM Satisfaction (SDM-Q): Evaluated during initial consent and treatment decisions
7. Prognostic Data
Date of Progression from MDS to AML
Survival Duration (Time from Diagnosis to Death/Censoring)
Mortality Status (Alive/Deceased)
Cause of Death (if applicable)
This structured format ensures clarity and aligns with standard medical terminology for international research contexts.
Management information
Registered date
| 2025 | Year | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066070
