UMIN-CTR Clinical Trial

Basic information
Public title	The study of the incidence, etiology and natural history of adrenal tumor
Acronym	The study of the incidence, etiology and natural history of adrenal tumor
Scientific Title	The study of the incidence, etiology and natural history of adrenal tumor
Scientific Title:Acronym	The study of the incidence, etiology and natural history of adrenal tumor
Region	Japan

Condition
Condition	adrenal tumor
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate that the incidence, etiology and natural history of adrenal tumor.
Basic objectives2	Others
Basic objectives -Others	To investigate that the incidence, etiology and natural history of adrenal tumor.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the incidence, etiology and natural history of adrenal tumor
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	patient who is newly diagnosed as adrenal tumor
Key exclusion criteria	patient who is unsuitable for this study (judged by a doctor)
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Michio Middle name Last name Otsuki
Organization	Osaka University Graduate School of Medicine
Division name	Department of Metabolic Medicine
Zip code	565-0871
Address	2-2 Yamada-oka, Suita, Osaka, Japan
TEL	06-6879-3732
Email	otsuki@endmet.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Michio Middle name Last name Otsuki
Organization	Osaka University Graduate School of Medicine
Division name	Department of Metabolic Medicine
Zip code	565-0871
Address	2-2 Yamada-oka, Suita, Osaka, Japan
TEL	06-6879-3732
Homepage URL
Email	otsuki@endmet.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Osaka University Graduate School of Medicine
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	The Osaka University Clinical Research Review Committee
Address	2-15 Yamada-oka, Suita, Osaka, Japan
Tel	06-6879-5682
Email	rinri@hp-crc.med.osaka-u.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	2010 Year 05 Month 28 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	110
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	Completed
Date of protocol fixation	2010 Year 03 Month 11 Day
Date of IRB	2010 Year 03 Month 11 Day
Anticipated trial start date	2010 Year 03 Month 11 Day
Last follow-up date	2021 Year 04 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	the incidence, etiology and natural history of adrenal tumor

Management information
Registered date	2010 Year 05 Month 28 Day
Last modified on	2021 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004450