UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009931 |
|---|---|
| Receipt number | 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 17:24:56 |
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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
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
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Kobe, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011400
