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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009931
Receipt No. R000011400
Scientific Title The pathophysiological analysis of abnormal growth hormone signaling
Date of disclosure of the study information 2013/02/01
Last modified on 2013/02/01

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Basic information
Public title The pathophysiological analysis of abnormal growth hormone signaling
Acronym Analysis of growth hormone signaling
Scientific Title The pathophysiological analysis of abnormal growth hormone signaling
Scientific Title:Acronym Analysis of growth hormone signaling
Region
Japan

Condition
Condition Patients with short stature, tall stature, acromegaly, or gigantism, patients without these diseases as a control
Classification by specialty
Endocrinology and Metabolism Dermatology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To elucidate the molecular pathogenesis of the abnormal growth hormone signaling for more appropriate treatment in these patients
Basic objectives2 Others
Basic objectives -Others To elucidate the pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Novel gene mutation related to abnormal growth hormone signaling
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Gene
Interventions/Control_1 A hundred cases of patients with short stature, tall stature, acromegaly, and gigantism, 100 cases of control patients. This could be changed with appropriate modification procedure. This study will conduct until March 31, 2016.
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 The patients with short stature, tall stature, acromegaly, and gigantism, or patient without these diseases as a control, who agreed with the study.
Key exclusion criteria 1) the patients who refused to the study
2) the patients who were redarded as inadequate by doctor
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Takahashi
Organization Kobe University Graduate School of Medicine, Kobe, Japan
Division name Division of Diabetes and Endocrinology
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kobe University Graduate School of Medicine, Kobe, Japan
Division name Division of Diabetes and Endocrinology
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
Homepage URL
Email

Sponsor
Institute Kobe University Graduate School of Medicine, Kobe, Japan
Institute
Department

Funding Source
Organization Kobe University Graduate School of Medicine, Kobe, Japan
Organization
Division
Category of Funding Organization Other
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 神戸大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 01 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
Results
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 Enrolling by invitation
Date of protocol fixation
2012 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 01 Day
Last modified on
2013 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011400

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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