UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055169 |
|---|---|
| Receipt number | R000063025 |
| Scientific Title | A prospective observational study to clarify the real-world evidence for relapsed acute lymphoblastic leukemia in children, adolescents and young adults |
| Date of disclosure of the study information | 2024/08/30 |
| Last modified on | 2025/02/06 14:26:54 |
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Basic information
Public title
A prospective observational study to clarify the real-world evidence for relapsed acute lymphoblastic leukemia in children, adolescents and young adults
Acronym
ALL-R23
Scientific Title
A prospective observational study to clarify the real-world evidence for relapsed acute lymphoblastic leukemia in children, adolescents and young adults
Scientific Title:Acronym
ALL-R23
Region
| Japan |
Condition
Condition
relapsed acute lymphoblastic leukemia in children, adolescents and young adults
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to understand the real-world treatment status and prognosis of relapsed acute lymphoblastic leukemia in children, adolescents, and young adults.
Basic objectives2
Others
Basic objectives -Others
Based on the data, we will obtain knowledge that will be useful for the development of new treatment methods, including innovative drugs, and for the planning of clinical research aimed at establishing a standard therapy in children and AYA.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Event free survival
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Relapsed acute lymphoblastic leukemia
Must be under 25 years of age at the time consent is obtained.
Must have been enrolled in the CHM-14 study.
Be enrolled in this study for the first time
Have written consent to participate in this study from the patient or a legal representative.
Key exclusion criteria
In case the principal investigator or research assignee determines that participation in this study is not appropriate.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Hidemi |
| Middle name | |
| Last name | Toyoda |
Organization
Mie University Hospital
Division name
Department of Pediatrics
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie
TEL
81592321111
htoyoda@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidemi |
| Middle name | |
| Last name | Toyoda |
Organization
Mie University Hospital
Division name
Department of Pediatrics
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie
TEL
81592321111
Homepage URL
htoyoda@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Review Board for Clinical Trials (Nagoya)
Address
4-1-1 Sannomaru, Naka-ku Nagoya, Aichi
Tel
81529511111
311-rec@mail.hosp.go.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
| 2024 | Year | 08 | Month | 30 | 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
| 2024 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to understand the real-world treatment status and prognosis of relapsed acute lymphoblastic leukemia (ALL) in children, adolescents, and young adults.
Management information
Registered date
| 2024 | Year | 08 | Month | 06 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063025
