UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005542 |
|---|---|
| Receipt number | 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 10:31:59 |
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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
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
Sponsor or person
Institute
The jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006515
