UMIN-CTR Clinical Trial

Basic information
Public title	Advancing Care of Adrenal diseases and Adrenal Registry in ASIA
Acronym	Adrenal Asia
Scientific Title	Advancing Care of Adrenal diseases and Adrenal Registry in ASIA
Scientific Title:Acronym	Advancing Care of Adrenal diseases and Adrenal Registry in ASIA
Region	Japan Asia(except Japan)

Condition
Condition	Pheochromocytoma, Cushing syndrome, subclinical Cushing syndrome, ACTH Independent Macronodular Adrenal Hyperplasia (AIMAH), Adrenocortical cancer, nonfunctioning adrenal tumor
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism Nephrology Endocrine surgery Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In the context of the major intractable adrenal diseases of PA, PHEO, CS, SCS, AIMAH, ACC, and NFA, the study objectives are to: 1) build a disease registry as an infrastructure in developing new diagnostic and therapeutic methods, to create a disease cohort, and to establish a multicenter collaborative research network 2) build evidence on diagnostic tests, treatment, and disease prognoses to improve the quality of clinical practice and its guidelines.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	a. Basic patient information (age, height and weight at initial presentation, sex, past medical history, family history, what led to discovery, outcome, complications, symptoms etc.) b. General laboratory test findings (blood counts, biochemistry, urinalyses etc.) *1 c. Endocrine test results (blood, urine) *2 d. Imaging findings (CT, MRI, FDG-PET, scintigraphy, etc.) e. Treatment (surgery [Y/N, date], Medication [Y/N, drug, dose, method of administration, duration of treatment], radiation [Y/N, date]
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients presenting to Kyoto Medical Center and other major medical centers across Japan and Asia who have been diagnosed with PA, PHEO, CS/SCS, AIMAH, ACC, or NFA between January 2006 and December 2018.
Key exclusion criteria	Not applicable
Target sample size	2400

Research contact person
Name of lead principal investigator	1st name Naruse Middle name Last name Mitsuhide
Organization	National Hospital Organization, Kyoto Medical Center
Division name	Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code	6128555
Address	1-1Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555, Japan
TEL	075-641-9161
Email	asiaoceania.panet@gmail.com

Public contact
Name of contact person	1st name Naruse Middle name Last name Mitsuhide
Organization	National Hospital Organization, Kyoto Medical Center
Division name	Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code	6128555
Address	1-1Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555, Japan
TEL	075-641-9161
Homepage URL
Email	asiaoceania.panet@gmail.com

Sponsor
Institute	National Hospital Organization, Kyoto Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization, Kyoto Medical Center
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	National Hospital Organization, Kyoto Medical Center
Address	1-1Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555, Japan
Tel	075-641-9161
Email	asiaoceania.panet@gmail.com

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

聖マリアンナ医科大学　横浜市西部病院　（神奈川県） 市立札幌病院（北海道） 国立国際医療研究センター（東京都） 京都大学（京都府） 鳥取大学（鳥取県） 兵庫医科大学(兵庫県） National Taiwan University Hospital, Taipei, Taiwan Chong Hua Hospital, Cebu City, Philippines North Shore Hospital, Auckland, New Zealand University Kebangsaan Malaysia Medical Center, Selangor, Malaysia Yonsei University College of Medicine, Seoul, Korea Fatmawati General Hospital, a tertiary /referral government Hospital , teaching hospital for internal medicine resident of University of Indonesia, Jakarta, Indonesia Seth G.S. Medical College & KEM Hospital, Parel Mumbai, India Hypertension Center of Xinjiang Provincial General Hospital, Xinjiang Hypertension Institute, Urumqi, China

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 17 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	1174
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	2017 Year 08 Month 10 Day
Date of IRB	2017 Year 09 Month 19 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multicenter, observation study.

Management information
Registered date	2019 Year 07 Month 17 Day
Last modified on	2021 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042635