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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024604
Receipt No. 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

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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
Email 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
Email k.nishimoto@keio.jp

Sponsor
Institute Keio University
Institute
Department

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
Email 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
URL(English) 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


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