UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036170 |
|---|---|
| Receipt number | R000041209 |
| Scientific Title | A prospective observational study to evaluate the predictive value of a newly developed software, Uni-APA Predictor, that distinguishes patients who can omit adrenal venous sampling for the diagnosis of unilateral primary aldosteronism. |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2020/09/13 22:00:25 |
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Basic information
Public title
A prospective observational study to evaluate the predictive value of a newly developed software, Uni-APA Predictor, that distinguishes patients who can omit adrenal venous sampling for the diagnosis of unilateral primary aldosteronism.
Acronym
A prospective observational study to evaluate the predictive value of a newly developed software, Uni-APA Predictor, that distinguishes patients who can omit adrenal venous sampling for the diagnosis of unilateral primary aldosteronism.
Scientific Title
A prospective observational study to evaluate the predictive value of a newly developed software, Uni-APA Predictor, that distinguishes patients who can omit adrenal venous sampling for the diagnosis of unilateral primary aldosteronism.
Scientific Title:Acronym
A prospective observational study to evaluate the predictive value of a newly developed software, Uni-APA Predictor, that distinguishes patients who can omit adrenal venous sampling for the diagnosis of unilateral primary aldosteronism.
Region
| Japan |
Condition
Condition
aldosterone-producing adenoma
Classification by specialty
| Medicine in general | Endocrine surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
in preparation
Basic objectives2
Others
Basic objectives -Others
in preparation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
in preparation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
in preparation
Key exclusion criteria
in preparation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koshiro |
| Middle name | |
| Last name | Nishimoto |
Organization
Saitama Medical University International Medical Center
Division name
UroOncology
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama 350-1241, Japan
TEL
+81-42-984-4111
k.nishimoto@keio.jp
Public contact
Name of contact person
| 1st name | Koshiro |
| Middle name | |
| Last name | Nishimoto |
Organization
Saitama Medical University International Medical Center
Division name
UroOncology
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama 350-1241, Japan
TEL
+81-42-984-4111
Homepage URL
k.nishimoto@keio.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center
Address
1397-1 Yamane, Hidaka, Saitama 350-1241, Japan
Tel
042-984-4523
chikens@saitama-med.ac.jp
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
埼玉医科大学国際医療センター（埼玉県）、横浜労災病院（神奈川県）、練馬光が丘病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 03 | Month | 12 | Day |
Last modified on
| 2020 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041209
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/05/20 | 実施計画書ver3.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
