UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042762 |
|---|---|
| Receipt number | R000048811 |
| Scientific Title | Survey of real-world evidence in treatment of patients with CML who desire for bearing children |
| Date of disclosure of the study information | 2020/12/15 |
| Last modified on | 2024/03/07 09:07:19 |
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Basic information
Public title
Survey of real-world evidence in treatment of patients with CML who desire for bearing children
Acronym
Survey of real-world evidence in treatment of patients with CML who desire for bearing children (preg-CML/JAPAN study)
Scientific Title
Survey of real-world evidence in treatment of patients with CML who desire for bearing children
Scientific Title:Acronym
Survey of real-world evidence in treatment of patients with CML who desire for bearing children
Region
| Japan |
Condition
Condition
Chronic Myelogenous Leukemia (CML)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of real-world evidence for pregnancy in young female patient with CML
Basic objectives2
Others
Basic objectives -Others
Retrospective observational study for CML treatment and pregnancy/delivery
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Investigation of real-world evidence for pregnancy in young female patient with CML
Key secondary outcomes
Relation between CML treatment and pregnancy/delivery.
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
1) Female parients with CML, who are/were treated at hematology department in Japan.
2) Diagnosed as chronic-phase CML between 1/1/2002 and 30/11/2020.
3) Diagnosed age was 45 years or younger.
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
South 4 West 25, Chuo-ku, Sapporo
TEL
+81-11-563-2211
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
064-0804
Address
South 4 West 25, Chuo-ku, Sapporo
TEL
+81-11-563-2211
Homepage URL
kondo@aiiku-hp.or.jp
Sponsor or person
Institute
"Investigation of real-world evidence for pregnancy in young female patient with CML" Study Group
Institute
Department
Personal name
Funding Source
Organization
Pfizer Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institutional review boards of Aiiku Hospital
Address
South 4 West 25, Chuo-ku, Sapporo
Tel
+81-11-563-2211
aiiku-rinri@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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 15 | 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
70
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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 03 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Retrospective observational study for CML treatment and pregnancy/delivery in young female patients with CML
Management information
Registered date
| 2020 | Year | 12 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048811
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
