UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A cross sectional study of Quality of Life in long-term pediatric survivors after autologous and allogeneic hematopoietic stem cell transplantation
Title of the study (Brief title)	QOL in pediatric survivors after hematopoietic stem cell transplantation
Region	Japan

Condition
Condition	Hematopoietic stem cell trans- plantation targeted diseases such as hematological/malignant diseases, primary immunodeficiency and severe congenital metabolic disease
Classification by specialty	Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To improve Quality of Life (QOL) in patients after transplantation by a cross sectional study of QOL in long-term survivors with hematopoietic stem cell transplantation.
Basic objectives2	Others
Basic objectives -Others	QOL
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	We will examine QOL of survivors which assessed by the comprehensive QOL instruments (SF-36 for 16 years or older and PedsQL Generic Core Scale for less than 16 years of age at the time of getting an informed consent), FACT-BMT and VAS described below. (1) SF-36 or PedsQL Generic Core Scale: Compare QOL of patients with that of same sex, coeval national certified value. (2) FACT-BMT: Examine factors associated with QOL. (3) To evaluate the following factors which are associated with QOL *Donor and type of transplantation in related and un-related allogeneic HSCT *Allogeneic or autologous HSCT *Conditioning regimens and total body irradiation *Years after transplantation, reintegration into society, connubiality and restoration of gonadal function *Chronic GVHD *Psychological influence including PTSS *With or without HSCT (4) Compare background factors of patients who are engaged in this study with who disapproved or unable to explain this study. (5) Compare patients who are included in this study and patients who are included in the pediatric study.
Key secondary outcomes

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 who received HSCT at younger than 20 years of age. (2)Patients who were transplanted at pediatric department. (3)Patients who survived for two years and above after last transplantation without relapse. (4)Patients who signed a written informed consents by themselves or legal guardians. (5)Patients who can read Japanese questionnaire. (6)Patients who are compatible with exclusion criteria.
Key exclusion criteria	(1)Patients who disapproved of TRUMP search. (2)Patients who are disqualified by his attending physician.
Target sample size	400

Research contact person
Name of lead principal investigator	Shuichi Taniguchi M.D.
Organization	Late Effects / Quality of Life Working Group, the Japan Society for Hematopietic Cell Tranplantation (Toranomon Hospital)
Division name	Department of Hematology
Address	2-2 Toranomon2-chome, Minato-ku, Tokyo, 105-8470 Japan
TEL	03-3588-1111
Email	taniguchi-s@toranomon.gr.jp

Public contact
Name of contact person	Yasushi Ishida, M.D.
Organization	Ehime Prefectural Central Hospital / St.Luke's International Hospital
Division name	Department of Pediatrics
Address	83 Kasuga-machi, Matsuyama-city, Ehime 790-0024 Japan
TEL	089-947-1111
Homepage URL	http://jshct.com
Email	yaishida@luke.or.jp

Sponsor
Institute	Late Effects / Quality of Life Working Group, the Japan Society for Hematopietic Cell Tranplantation
Institute
Department

Funding Source
Organization	The Clinical research committee of the Japan Society for Hematopietic Cell Tranplantation
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of HSCT Data Management and Biostatistics
Name of secondary funｄer(s)

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	2012 Year 12 Month 15 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 12 Month 06 Day
Anticipated trial start date	2012 Year 12 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This is a cross-sectional observational study. Long-term survivors without relapse after hematopoietic stem cell transplantation, who fulfill inclusion criteria, who visited participating centers during the registration period (one year) are the subjects for this study.

Management information
Registered date	2012 Year 12 Month 14 Day
Last modified on	2017 Year 01 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010962