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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002195
Receipt No. R000002698
Scientific Title Functional analysis of mutations in calcium sensing receptor gene
Date of disclosure of the study information 2009/07/14
Last modified on 2010/01/14

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Basic information
Public title Functional analysis of mutations in calcium sensing receptor gene
Acronym Functional analysis of mutant CaSR
Scientific Title Functional analysis of mutations in calcium sensing receptor gene
Scientific Title:Acronym Functional analysis of mutant CaSR
Region
Japan

Condition
Condition The family of multiple endocrine neoplasia (MEN) type 2A
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To identify the novel mutations in CaSR gene on MEN type 2A family, and to analyse those functions on Ca levels.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Identification of novel mutations in CaSR gene
2) Functional analysis of Ca sensing ability in CaSR mutants
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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Family member of MEN type 2A
Key exclusion criteria Nothing but above
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Kondo
Organization Faculty of Medical and Pharmaceutical Sciences, Kumamoto University
Division name Metabolic Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto
TEL +81-96-373-5169
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Kondo
Organization Faculty of Medical and Pharmaceutical Sciences, Kumamoto University
Division name Metabolic Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto
TEL +81-96-373-5169
Homepage URL
Email t-kondo@gpo.kumamoto-u.ac.jp

Sponsor
Institute Faculty of Medical and Pharmaceutical Sciences, Kumamoto University
Institute
Department

Funding Source
Organization Faculty of Medical and Pharmaceutical Sciences, Kumamoto University, Metabolic Medicine
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 07 Month 14 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 Terminated
Date of protocol fixation
2009 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2010 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1) Identification of novel CaSR mutations
2) Functional analysis of mutant CaSR

Management information
Registered date
2009 Year 07 Month 14 Day
Last modified on
2010 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002698

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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