臨床研究等提出・公開システム

Date of registration	Dec. 15, 2022
Last modified on	Dec. 15, 2022
Trial ID	jRCT1050220134

Scientific Title	Long-term observational study for pediatric brain tumors (PBT-LTFU)
Public Title	Long-term observational study for pediatric brain tumors (PBT-LTFU)

Contact for Scientific Queries	Name	Fujisaki Hiroyuki
	Affiliation	Osaka City General Hospital
	Address	2-13-22, Miyakozima Hondori, Miyakozima-ku, Osaka, Japan
	Telephone	+81-669291221
	E-mail	h-fujisaki@med.osakacity-hp.or.jp
Contact for Public Queries	Name	Yamasaki Kai
	Affiliation	Osaka City General Hospital
	Address	2-13-22, Miyakozima Hondori, Miyakozima-ku, Osaka, Japan
	Telephone	+81-669291221
	E-mail	ka-yamasaki@med.osakacity-hp.or.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 15, 2022
Actual date of first enrollment		Sept. 25, 2020
Target sample size		1000
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients with brain tumors younger than 30 years old at diagnosis (histology is not limited). 2) Registration of the JCCG pediatric solid tumor observation study has been completed at the time of participation in this study. 3) Registration for the other prospective interventional study for pediatric brain tumors conducted by JCCG is completed. 3) At the same time as this study, the patient is enrolled or will be enrolled in a prospective clinical study conducted by the JCCG Brain Tumor Committee. 4) Written informed consent from the patient and/or legally acceptable proxy has been obtained.
	Exclusion Criteria	Patients who are unable to evaluate the late effects.
	Age Minimum	0age over
	Age Maximum	30age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pediatric brain tumor
Health Condition(s) Keyword		brain tumor
Health Condition(s) Code		D001932
Primary Outcome(s)		Overall survival rate at 20 years
Secondary Outcome(s)		Overall survival rates at 5 and 10 years Progression-free survival rate at 5 and 10 years Rate of late complications (Neurocognitive, Endroine, Cardiovascular, Fertility, Stroke, etc) Rate of secondary neoplasms Social outcomes Rate and causes of late mortalities

Primary Sponsor	Department of pediatric hematology and oncology, Osaka City General Hospital

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Institutional review board, Osaka City General Hospital
Address	2-13-22, Miyakozima Hondori, Miyakozima-ku, Osaka, Japan, Osaka
Telephone	+81-669291221
E-Mail	ka-yamasaki@med.osakacity-hp.or.jp
Approval Status	Approval
Date of approval	Sept. 01, 2020

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none