UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of QOL in children with short stature after initiation of growth hormone therapy.
Acronym	GT-QOL
Scientific Title	Evaluation of QOL in children with short stature after initiation of growth hormone therapy.
Scientific Title:Acronym	GT-QOL
Region	Japan

Condition
Condition	small stature caused by growth hormone deficiency, Turner syndrome, or small for gestational age
Classification by specialty	Pediatrics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the change in QOL of children with small stature after initiation of growth hormone therapy using a questionnaire.
Basic objectives2	Others
Basic objectives -Others	QOL of patients.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of QOL after 6 months and 12 months of growth hormone therapy compared with pretreatment.
Key secondary outcomes	-Comparison of QOL of patients with that of normal children. -Comparison of QOL measured by parents with that by patients themselves who are supposed to be able to answer the questionnaire.

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Children with short stature caused by -growth hormone deficiency -Turner syndrome -small for gestational age whose epiphyseal growth plates remain unclosed. -Never received growth hormone therapy before. -Written informed consent.
Key exclusion criteria	-Contraindication for Growject -Patients (or parents) who are not supposed to be able to answer the questionnaire appropriately. -Judgement of physicians.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shinobu Middle name Last name Ida
Organization	Osaka Women's and Children's Hospital
Division name	Department of Pediatric Gastroenterology and Endocrinology
Zip code	594-1101
Address	840 Murodo-cho, Izumi, Osaka, 594-1101, Japan
TEL	0725-56-1220
Email	idas@wch.opho.jp

Public contact
Name of contact person	1st name Shinobu Middle name Last name Ida
Organization	Osaka Women's and Children's Hospital
Division name	Department of Pediatric Gastroenterology and Endocrinology
Zip code	594-1101
Address	840 Murodo-cho, Izumi, Osaka, 594-1101, Japan
TEL	0725-56-1220
Homepage URL
Email	idas@wch.opho.jp

Sponsor
Institute	JCR pharmaceuticals Co., Ltd.
Institute
Department

Funding Source
Organization	JCR pharmaceuticals Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of Osaka Women's and Children's Hospital
Address	840 Murodo-cho, Izumi, Osaka, 594-1101, Japan
Tel	0725-56-1220
Email	idas@wch.opho.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	2017 Year 03 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	117
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	in preparation for publication
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	Completed
Date of protocol fixation	2016 Year 09 Month 02 Day
Date of IRB	2016 Year 08 Month 31 Day
Anticipated trial start date	2016 Year 11 Month 18 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 06 Month 19 Day

Other
Other related information	To evaluate the change in QOL of children with small stature after initiation of growth hormone therapy using a questionnaire.

Management information
Registered date	2017 Year 03 Month 15 Day
Last modified on	2022 Year 05 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028797