UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of clinical parameters for screening the patients with overt/subclinical Cushings syndrome complicated with or without hyperaldosteronism in order to clarify pathogenesis of hypertension in those patients.
Title of the study (Brief title)	The pathogenesis of hypertension in the patients with subclinical Cushings syndrome.
Region	Japan

Condition
Condition	Overt Cushings syndrome and Subclinical Cushings syndrome
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We assess the frequency of complication of hyperaldosteronism among patients with overt/subclinical Cushings syndrome.
Basic objectives2	Others
Basic objectives -Others	We try to detect simple and useful parameters for accurately diagnosing overt/subclinical Cushings syndrome complicated with/without primary aldosteronism(PA). We also establish the methods of the best treatment for those patients, according to each clinical characteristic. Furthermore, we would like to follow the clinical course after adrenalectomy between the cases with/without PA.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The frequency of hypertensive complications, induced by hyperaldosteronism in patients with overt/subclinical Cushings syndrome.
Key secondary outcomes	Improvement of endocrine function and complications for these statuses after adrenalectomy.

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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who have adrenal incidentaloma and are suspected to have hypercortisolism.
Key exclusion criteria	Patients who reject the areement.
Target sample size	50

Research contact person
Name of lead principal investigator	Omura Masao
Organization	Yokohama Rosai Hospital
Division name	Endocrinology & Diabetes Center
Address	3211, Kozukue-cho, Kohoku-ku, Yokohama City, Kanagawa, Japan
TEL	045-474-8111
Email	omura@yokohamah.rofuku.go.jp

Public contact
Name of contact person	Kosuke Inoue
Organization	Yokohama Rosai Hospital
Division name	Endocrinology & Diabetes Center
Address	3211, Kozukue-cho, Kohoku-ku, Yokohama City, Kanagawa, Japan
TEL	045-474-8111
Homepage URL
Email	koinoue-tky@umin.ac.jp

Sponsor
Institute	Yokohama Rosai Hospital
Institute
Department

Funding Source
Organization	Yokohama Rosai Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 05 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 12 Month 01 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Open public recruiting

Management information
Registered date	2016 Year 05 Month 01 Day
Last modified on	2017 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025435