UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026570 |
|---|---|
| Receipt number | R000028797 |
| Scientific Title | Evaluation of QOL in children with short stature after initiation of growth hormone therapy. |
| Date of disclosure of the study information | 2017/03/15 |
| Last modified on | 2022/05/31 16:37:43 |
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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
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
idas@wch.opho.jp
Sponsor or person
Institute
JCR pharmaceuticals Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028797
