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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034378
Receipt No. R000039195
Scientific Title Study for efficacy of measuring plasma progesterone during adrenal venous sampling in patients with primary aldosteronism
Date of disclosure of the study information 2018/10/04
Last modified on 2019/04/09

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Basic information
Public title Study for efficacy of measuring plasma progesterone during adrenal venous sampling in patients with primary aldosteronism
Acronym Efficacy of measuring plasma progesterone during AVS
Scientific Title Study for efficacy of measuring plasma progesterone during adrenal venous sampling in patients with primary aldosteronism
Scientific Title:Acronym Efficacy of measuring plasma progesterone during AVS
Region
Japan

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

Objectives
Narrative objectives1 To study of efficacy for diagnosis where the aldosterone producing tumor is localized by measuring plasma progesterone levels during adrenal venous sampling.
Basic objectives2 Others
Basic objectives -Others Exploration
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To study the efficacy for diagnosis of localization of aldosterone producing tumor by using ratio of aldosterone to progesterone compared with ratio of aldosterone to cortisol.
Key secondary outcomes To study the efficacy for diagnosis of localization of aldosterone producing tumor by using ratio of aldosterone to progesterone even in patients complicated with Cushing's syndrome.

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients underwent adrenal venous sampling in Nagasaki University Hospital
Key exclusion criteria Patients administered with steroid.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Horie
Organization Nagasaki University
Division name Endocrinology and Metabolism
Zip code 852-8501
Address Sakamoto1-7-1, Nagasaki
TEL 0958197200
Email holy197741@me.com

Public contact
Name of contact person
1st name Ichiro
Middle name
Last name Horie
Organization Nagasaki University
Division name Endocrinology and Metabolism
Zip code 852-8501
Address Sakamoto1-7-1, Nagasaki
TEL 0958197200
Homepage URL
Email holy197741@me.com

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki University
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 Nagasaki University Hospital Clinical Study Review Board
Address 1-7-1 Sakamoto, Nagasaki
Tel 095-819-7200
Email holy197741@me.com

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
2018 Year 10 Month 04 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 Enrolling by invitation
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
2015 Year 04 Month 01 Day
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information On going

Management information
Registered date
2018 Year 10 Month 04 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039195

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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