UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057808 |
|---|---|
| Receipt number | R000066071 |
| Scientific Title | AML-PLT |
| Date of disclosure of the study information | 2025/05/09 |
| Last modified on | 2025/05/09 08:48:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prognostic value of initial platelet count in older patients with high-risk acute myeloid leukemia: a prospective observational study
Acronym
AML-PLT
Scientific Title
AML-PLT
Scientific Title:Acronym
AML-PLT
Region
| Japan |
Condition
Condition
older patients with high-risk acute myeloid leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate a treatment selection algorithm that integrates patient-reported outcomes (PROs) and shared decision-making (SDM) in patients aged 65 years or older who have just been diagnosed with AML.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival rate one year after diagnosis
Key secondary outcomes
Overall survival
Disease-free survival
Remission rate
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
| 65 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Newly diagnosed high-risk AML patients
2) Age: 65 years or older
Key exclusion criteria
1) Patients with a history of previous treatment for AML
2) Patients with severe comorbidities
3) Patients for whom it is difficult to obtain consent
Target sample size
27
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
Clinical Information Collected from Medical Records
(For Study Participants)
1. Patient Basic Information
Age
Gender
Details of AML diagnosis (including subtype per WHO classification)
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 and Molecular Testing:
AML 2022 European LeukemiaNet (ELN) Genetic Risk Classification (Favorable, Intermediate, Adverse)
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 (if applicable)
Survival Duration (Time from Diagnosis to Death/Censoring)
Mortality Status (Alive/Deceased)
Cause of Death (if applicable)
Key References:
ELN 2022 classification integrates cytogenetic and molecular markers for AML risk stratification.
QOL-ACD and SDM-Q are validated tools for assessing patient-reported outcomes and decision-making quality in hematologic malignancies.
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=R000066071
