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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005542
Receipt No. R000006515
Scientific Title Verification of each voltage-gated calcium channel's distribution pattern in an aldosterone-producing adenoma
Date of disclosure of the study information 2011/05/06
Last modified on 2011/12/06

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Basic information
Public title Verification of each voltage-gated calcium channel's distribution pattern in an aldosterone-producing adenoma
Acronym Verification of each voltage-gated calcium channel's distribution pattern in an aldosterone-producing adenoma
Scientific Title Verification of each voltage-gated calcium channel's distribution pattern in an aldosterone-producing adenoma
Scientific Title:Acronym Verification of each voltage-gated calcium channel's distribution pattern in an aldosterone-producing adenoma
Region
Japan

Condition
Condition primary hyperaldosteronism
Classification by specialty
Medicine in general Endocrinology and Metabolism Endocrine surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of various types of calcium channel expression in human adrenal gland tumor
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Verification of various types of calcium channel localization in human adrenal gland tumor
Key secondary outcomes Verification of sympathetic nerve distribution in human adrenal gland tumor

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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. a patient between 20 and 75 years of age
2. a patient with primary aldosteronism
3. a patient who requires adrenalectomy or has already adrenalectomized.
4. a patient who gives informed concent

a patient who fulfills the conditions set forth above



Key exclusion criteria 1. a patient who is incapable of giving valid informed consent because of dementia or neuropsychiatric disorder
2. a patient has deemed unsuitable by attending physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuyoshi Tojo
Organization The jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 3-19-18, Nishishinbashi, Minato-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The jikei University School of Medicine
Division name Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 3-19-18, Nishishinbashi, Minato-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute The jikei University School of Medicine
Institute
Department

Funding Source
Organization The jikei University School of 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
2011 Year 05 Month 06 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 Open public recruiting
Date of protocol fixation
2011 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Verification of various types of calcium channel localization in human adrenal gland tumor
Verification of sympathetic nerve distribution in human adrenal gland tumor

Management information
Registered date
2011 Year 05 Month 02 Day
Last modified on
2011 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006515

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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