UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061115 |
|---|---|
| Receipt number | R000069770 |
| Scientific Title | A Multicenter, Prospective Observational Study of Symptom Reporting in Patients with Chronic Myeloid Leukemia (CML) Using a Digital Tool |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/03/31 15:47:09 |
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Basic information
Public title
A Multicenter, Prospective Observational Study of Symptom Reporting in Patients with Chronic Myeloid Leukemia (CML) Using a Digital Tool
Acronym
A Multicenter, Prospective Observational Study of Symptom Reporting in Patients with Chronic Myeloid Leukemia (CML) Using a Digital Tool
Scientific Title
A Multicenter, Prospective Observational Study of Symptom Reporting in Patients with Chronic Myeloid Leukemia (CML) Using a Digital Tool
Scientific Title:Acronym
A Multicenter, Prospective Observational Study of Symptom Reporting in Patients with Chronic Myeloid Leukemia (CML) Using a Digital Tool
Region
| Japan |
Condition
Condition
Chronic Myeloid Leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the feasibility and acceptability of a digital solution designed to address key clinical challenges in the management of chronic myeloid leukemia (CML), including assessment of non-hematologic symptoms, patient quality of life (QOL), and medication adherence.
We will utilize an electronic patient-reported outcome (ePRO) tool (YaDoc_CML Symptom Report) implemented within the online disease management system YaDoc. Adult patients with CML receiving tyrosine kinase inhibitor (TKI) therapy will use this tool for a defined period.
The primary evaluation includes usage rate and patient satisfaction. In addition, healthcare providers will complete questionnaires to assess feasibility and acceptability in clinical practice. The overall evaluation will be conducted from both patient and healthcare provider perspectives.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Primary Endpoint
Utilization rate of the YaDoc_CML Symptom Report (completion rate of questionnaire entries)
2. Secondary Endpoints
Patient satisfaction after use of the YaDoc_CML Symptom Report
Healthcare provider satisfaction after use of the YaDoc_CML Symptom Report
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients aged over 18 years at the time of informed consent.
2 Patients who are able to understand the study and provide written informed consent.
3 Smartphone users (iOS version 15.7 or later, Android OS version 8.0 or later, 9.0 or later recommended), excluding unsupported devices (e.g., RakuRaku smartphones, Simple smartphones, iPod Touch iPad mini, iPhone 6 or earlier models, Microsoft Surface devices, all Android tablets, and certain Android smartphones such as HUAWEI devices).
4 Patients with chronic myeloid leukemia (CML) who receive tyrosine kinase inhibitor (TKI) therapy at participating institutions between October 1, 2026, and September 30, 2027.
Key exclusion criteria
1 Patients who have difficulty understanding or operating YaDoc and/or a smartphone.
2 Patients deemed inappropriate for participation in this study by the principal investigator or sub-investigators.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Tomoiku |
| Middle name | |
| Last name | Takaku |
Organization
Saitama Medical University Hospital
Division name
Hematology
Zip code
3500495
Address
Morohongo 38, Moroyama-cho, Iruma-gun, Saitama
TEL
0492761111
ttakaku@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoiku |
| Middle name | |
| Last name | Takaku |
Organization
Saitama Medical University Hospital
Division name
Hematology
Zip code
3500495
Address
Morohongo 38, Moroyama-cho, Iruma-gun, Saitama
TEL
0492761111
Homepage URL
ttakaku@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University Hospital
Address
Morohongo 38, Moroyama-cho, Iruma-gun, Saitama
Tel
0492761111
ttakaku@saitama-med.ac.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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
ecord patient-reported symptoms, treatment-related adverse events, and medication adherence
Management information
Registered date
| 2026 | Year | 03 | Month | 31 | Day |
Last modified on
| 2026 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069770
