UMIN-CTR Clinical Trial

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	Enrolling by invitation
Date of protocol fixation	2021 Year 02 Month 08 Day
Date of IRB	2021 Year 03 Month 04 Day
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	2022 Year 02 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049445