UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034378 |
|---|---|
| Receipt number | 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 | 2021/04/12 20:14:33 |
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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
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
holy197741@me.com
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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 | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | 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
| 2021 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039195
