UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037396 |
|---|---|
| Receipt number | R000042635 |
| Scientific Title | Advancing Care of Adrenal diseases and Adrenal Registry in ASIA |
| Date of disclosure of the study information | 2019/07/17 |
| Last modified on | 2021/07/20 11:59:41 |
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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
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
asiaoceania.panet@gmail.com
Sponsor or person
Institute
National Hospital Organization, Kyoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042635
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
