UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061501 |
|---|---|
| Receipt number | R000070371 |
| Scientific Title | A Clinical Survey of Reproductive-Age Patients with CML |
| Date of disclosure of the study information | 2026/05/08 |
| Last modified on | 2026/05/08 20:45:09 |
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Basic information
Public title
A Clinical Survey of Reproductive-Age Patients with CML
Acronym
A Clinical Survey of Reproductive-Age Patients with CML
Scientific Title
A Clinical Survey of Reproductive-Age Patients with CML
Scientific Title:Acronym
A Clinical Survey of Reproductive-Age Patients with CML
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 investigate the clinical realities surrounding the onset of Chronic Myeloid Leukemia (CML) and fertility-related issues in young female patients with CML (45 years or younger at disease onset). We will examine patients' family and social circumstances and the medical care they received at the time of CML onset, as well as the challenges and barriers related to considering pregnancy during the course of CML treatment and the practical difficulties associated with pregnancy and childbirth. By clarifying these issues from medical, psychosocial, and economic perspectives, including the understanding and support of partners and family members, as well as financial burdens related to medical expenses, this study aims to identify the psychological and social challenges faced by these patients and provide feedback to improve future medical care.
Basic objectives2
Others
Basic objectives -Others
This study aims to investigate the clinical realities surrounding the onset of Chronic Myeloid Leukemia (CML) and fertility-related issues in young female patients with CML (45 years or younger at disease onset). We will examine patients' family and social circumstances and the medical care they received at the time of CML onset, as well as the challenges and barriers related to considering pregnancy during the course of CML treatment and the practical difficulties associated with pregnancy and childbirth. By clarifying these issues from medical, psychosocial, and economic perspectives, including the understanding and support of partners and family members, as well as financial burdens related to medical expenses, this study aims to identify the psychological and social challenges faced by these patients and provide feedback to improve future medical care.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Provision of fertility-related information to female patients diagnosed with CML during reproductive age
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
| Not applicable |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Young female patients with CML (45 years or younger at disease onset).
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kondo |
Organization
Aiiku Hospital
Division name
Blood Disorders Center
Zip code
064-0804
Address
2-1 Minami 4 Nishi 25, Chuo-ku, Sapporo
TEL
+81115632211
kondo@aiiku-hp.or.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kondo |
Organization
Aiiku Hospital
Division name
Blood Disorders Center
Zip code
063-0004
Address
2-1 Minami 4 Nishi 25, Chuo-ku, Sapporo
TEL
+81115632211
Homepage URL
kondo@aiiku-hp.or.jp
Sponsor or person
Institute
Aiiku Hospital
Institute
Department
Personal name
Takeshi Kondo
Funding Source
Organization
Aiiku Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aiiku Hospital IRB
Address
Minami 4 Nishi 25, Chuo-ku Sapporo
Tel
+81115632211
kondo@aiiku-hp.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
Hokkaido
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 08 | 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 | 03 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
questionnaire-based survey study
Management information
Registered date
| 2026 | Year | 05 | Month | 08 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070371
