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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002945
Receipt No. R000003552
Scientific Title Measurement of steroid fraction in adrenal venous samples of primary aldosteronism
Date of disclosure of the study information 2009/12/28
Last modified on 2015/08/11

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Basic information
Public title Measurement of steroid fraction in adrenal venous samples of primary aldosteronism
Acronym Steroid profiling of AVS in PA
Scientific Title Measurement of steroid fraction in adrenal venous samples of primary aldosteronism
Scientific Title:Acronym Steroid profiling of AVS in PA
Region
Japan

Condition
Condition Primary Aldosteronism
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To distinguish between aldosterone-producing adenoma and idiopathic hyperaldosteronism by measurement of hybrid steroid fraction in adrenal venous samples.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between steroid profile in AVS and PA classification
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria PA patients who underwent adrenal venous sampling
Key exclusion criteria not applicable
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isao Kurihara
Organization School of Medicine, Keio University
Division name Intenal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3796
Email i-kuri@dc4.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Isao Kurihara
Organization School of Medicine, Keio University
Division name Intenal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3796
Homepage URL
Email i-kuri@dc4.so-net.ne.jp

Sponsor
Institute Departement of Internal Medicine, School of Medicine, Keio University
Institute
Department

Funding Source
Organization Departement of Internal Medicine, School of Medicine, Keio University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Teikokuzoki Medical
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 慶應義塾大学病院

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 28 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
2009 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2009 Year 12 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 Teikokuzoki medical inc. will measure hybrid steroid fraction in AVS samples and we will determine cut-off value between APA and IHA.

Management information
Registered date
2009 Year 12 Month 25 Day
Last modified on
2015 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003552

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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