UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045155 |
|---|---|
| Receipt number | R000051583 |
| Scientific Title | Observational study of 6 mercaptopurine in pediatric acute lymphoblastic leukemia |
| Date of disclosure of the study information | 2021/08/14 |
| Last modified on | 2021/08/14 12:47:24 |
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Basic information
Public title
Adherence in pediatric ALL
Acronym
Adherence in pediatric ALL
Scientific Title
Observational study of 6 mercaptopurine in pediatric acute lymphoblastic leukemia
Scientific Title:Acronym
Adherence of 6-MP in pediatric ALL
Region
| Japan |
Condition
Condition
Acute lymphoblastic leukemia
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to assess the adherence of 6-MP used as maintenance therapy of pediatric acute lymphoblastic leukemia.
Basic objectives2
Others
Basic objectives -Others
Evaluating adherence
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of this study is the adherence of 6-MP.
Key secondary outcomes
1. the proportion of the patients with adherence higher than 90%.
2. Cluster analysis by drawing scatter plots of 6-MMP and 6-TGN concentrations.
3. Chronological changes of adherence.
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
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients under 20 years old on diagnosis who will initiate 6-MP as maintenance therapy for ALL.
2. Patients who provide written informed consents.
Key exclusion criteria
1. Patients with relapsed ALL.
2. Patients who can not provide informed consent.
3. Other reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Reo |
| Middle name | |
| Last name | Tanoshima |
Organization
Yokohama City University Hospital
Division name
Pediatrics
Zip code
236-0004
Address
Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2800
reotano@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Reo |
| Middle name | |
| Last name | Tanoshima |
Organization
Yokohama City University Hospital
Division name
Pediatrics
Zip code
236-0004
Address
Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2800
Homepage URL
reotano@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
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
Yokohama City University Hospidal
Address
Fukuura 3-9, Kanazawa-ku,Yokohama, Kanagawa, Japan
Tel
045-787-2800
rinri@yokohama-cu.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
| 2021 | Year | 08 | Month | 14 | 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
| 2020 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 19 | 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
Counting packages and concentrations of metabolites of 6-MP will be performed.
Management information
Registered date
| 2021 | Year | 08 | Month | 14 | Day |
Last modified on
| 2021 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051583
| 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 |
