UMIN-CTR Clinical Trial

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
Email	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
Email	reotano@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051583