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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043309
Receipt No. R000049445
Scientific Title Prospective observational study of lymphoma in children, adolescents and young adults
Date of disclosure of the study information 2021/02/15
Last modified on 2021/02/12

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Basic information
Public title Prospective observational study of lymphoma in children, adolescents and young adults
Acronym Prospective observational study of lymphoma in children, adolescents and young adults
Scientific Title Prospective observational study of lymphoma in children, adolescents and young adults
Scientific Title:Acronym PL-19
Region
Japan

Condition
Condition Lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the type and prognosis of all patients with lymphoma in children, adolescent and young adult in Japan
Basic objectives2 Others
Basic objectives -Others To evaluate the type and prognosis of all patients with lymphoma in children, adolescent and young adult according treatment method in Japan
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival period of each lymphoma
Key secondary outcomes Event free survival period of each lymphoma
relapse and progression time of each lymphoma
occurrence rate of second malignancy in each lymphoma
Overall survival period according each treatment method
Event free survival period according each treatment method
Relapse time according each treatment method

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
30 years-old >
Gender Male and Female
Key inclusion criteria lymphoma using WHO calcification (exclude leukemia)
Under 30 year-old at initial diagnosis
Patients who agree with registration of JPLSG CHM-14
Patients who agree with registration of JPLSG PL-19 (this study)
Key exclusion criteria Lymphoblastic leukemia
Target sample size 1300

Research contact person
Name of lead principal investigator
1st name Ryoji
Middle name
Last name Kobayashi
Organization Sapporo Hokuyu hospital
Division name Department of Hematology/Oncology for Children and Adolescents
Zip code 003-0006
Address 6-6 HigashiSapporo Shiroishiku Sapporo Hokaido
TEL 0118650111
Email r-koba@jacls.jp

Public contact
Name of contact person
1st name Daiki
Middle name
Last name Hori
Organization Sapporo Hokuyu hospital
Division name Department of Hematology/Oncology for Children and Adolescents
Zip code 003-0006
Address 6-6 HigashiSapporo Shiroishiku Sapporo Hokaido
TEL 011-865-0111
Homepage URL
Email pippen33_dh@yahoo.co.jp

Sponsor
Institute Japan Children's Cancer Group
Institute
Department

Funding Source
Organization Japan Agency for Medial 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 Sapporo Hokuyu hospital
Address 6-6 Higashisapporo Shiroishiku Sapporo Hokkaido
Tel 0118650111
Email r-koba@jacls.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 02 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
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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2021 Year 03 Month 15 Day
Last follow-up date
2037 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information this is observation study of all patients with lymphoma in children, adolescent and young adult.

Management information
Registered date
2021 Year 02 Month 12 Day
Last modified on
2021 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049445

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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