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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000529
Receipt No. R000000631
Scientific Title Gene analysis associated with short stature and growth hormone responsiveness
Date of disclosure of the study information 2006/12/01
Last modified on 2015/05/28

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Basic information
Public title Gene analysis associated with short stature and growth hormone responsiveness
Acronym Gene analysis associated with short stature and growth hormone responsiveness
Scientific Title Gene analysis associated with short stature and growth hormone responsiveness
Scientific Title:Acronym Gene analysis associated with short stature and growth hormone responsiveness
Region
Japan

Condition
Condition famirial short stature, idopathic short stature, Noonan syndrome, and good/poor respoders of growth hormone therapy
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 1)Invetigation of the cause of human growth failure in association with known genes related to growth, 2)identification of causing gene of growth failure such as intrauterine growth retardation and Noonan syndrome, and 3)investigation of gene responsiveness to growth hormone therapy
Basic objectives2 Others
Basic objectives -Others Invstigation of cause of the diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes gene analysis and functional assay
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients of growth impairment 1) who are informed that he or she might have agenetic disease, 2) who can see the pediatric endocrinologist and can
Key exclusion criteria none
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonobu Hasegawa
Organization Keio University, School of Medicine
Division name Department of Pediatrics
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email thaseg@a6.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomonobu Hasegawa
Organization Keio University, School of Medicine
Division name Department of Pediatrics
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email thaseg@a6.keio.jp

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization Foundation for Growth Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2006 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://press.endocrine.org/doi/abs/10.1210/jc.2013-3525
Number of participants that the trial has enrolled
Results
We identified heterozygous NPR2 mutations in 2% of Japanese patients with short
stature. Our in vitro findings indicate that NPR2 mutations have a dominant negative effect, and
their dominant-negative mechanisms vary corresponding to the molecular pathogenesis of the
mutations. (J Clin Endocrinol Metab 99: E713, 2014)
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 Completed
Date of protocol fixation
2004 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 06 Month 01 Day
Last follow-up date
2009 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We identified heterozygous NPR2 mutations in 2% of Japanese patients with short
stature.

Management information
Registered date
2006 Year 11 Month 27 Day
Last modified on
2015 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000631

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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