UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024604 |
|---|---|
| Receipt number | R000028310 |
| Scientific Title | Pathophysiology and pathology diagnosis of adrenocortical disease causing aldosterone and cortisol excess |
| Date of disclosure of the study information | 2016/10/28 |
| Last modified on | 2020/11/08 13:32:26 |
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Basic information
Public title
Pathophysiology and pathology diagnosis of adrenocortical disease causing aldosterone and cortisol excess
Acronym
Pathophysiology and pathology aldosterone/cortisol excess diseases
Scientific Title
Pathophysiology and pathology diagnosis of adrenocortical disease causing aldosterone and cortisol excess
Scientific Title:Acronym
Pathophysiology and pathology aldosterone/cortisol excess diseases
Region
| Japan |
Condition
Condition
primary aldosteronism
Cushing's syndrome
subclinical Cushing's syndrome
adrenocortical carcinoma
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Endocrine surgery | Urology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to understand pathophysiology of adrenal diseases using anti-P450 aldo and anti-P450 11beta antibodies
Basic objectives2
Others
Basic objectives -Others
To elucidate patho-physiology of aldosterone/cortisol producing lesions
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
If surgical specimens have positive areas of P450-aldo and P450 11beta, we judge them as aldosterone and cortisol producing lesions, respectively.
Key secondary outcomes
Genetic abnormality will be detected in the aldosterone/cortisol producing lesions.
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
primary aldosteronism: 200 cases
Cushing's syndrome: 60 cases
adrenocortical carcinoma: 10 cases
adrenocortical incidentalomas: 50 cases
others (pheochromocytoma, sex hormone producing tumor, etc.): 50 cases
Key exclusion criteria
not applicable
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Mototsugu |
| Middle name | |
| Last name | Oya |
Organization
Keio University
Division name
Urology
Zip code
160-8582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-3353-1211
moto-oya@z3.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
TEL
042-984-4111
Homepage URL
k.nishimoto@keio.jp
Sponsor or person
Institute
Keio University
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
Keio University School of Medicine
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | 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
For removed adrenal gland, histochemistry, immunohistochemistry, Western blot analyses, matrix assisted Laser Desorption/Ionization analyses (MALDI-TOFMS), liquid choromatography mass spectrometry (LC-MS), quantitative PCR analyses, and genetic analyses will be performed.
For collected blood sample, MALDI-TOFMS, LC-MS, and genetic analyses will be performed.
Management information
Registered date
| 2016 | Year | 10 | Month | 28 | Day |
Last modified on
| 2020 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028310
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/10/28 | documents (1).pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
