UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002195
Receipt number 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 14:20:31

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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 or person

Institute

Faculty of Medical and Pharmaceutical Sciences, Kumamoto University

Institute

Department

Personal name



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

Value
https://center6.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