UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021437 |
|---|---|
| Receipt number | R000024726 |
| Scientific Title | Advancing Care and Pathogenesis of Intractable Adrenal diseases in Japan |
| Date of disclosure of the study information | 2016/03/11 |
| Last modified on | 2022/03/17 10:20:10 |
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Basic information
Public title
Advancing Care and Pathogenesis of Intractable Adrenal diseases in Japan
Acronym
Advancing Care and Pathogenesis of Intractable Adrenal diseases in Japan
Scientific Title
Advancing Care and Pathogenesis of Intractable Adrenal diseases in Japan
Scientific Title:Acronym
Advancing Care and Pathogenesis of Intractable Adrenal diseases in Japan
Region
| Japan |
Condition
Condition
Pheochromocytoma, Cushing syndrome, subclinical Cushing syndrome, ACTH Independent Macronodular Adrenal Hyperplasia (AIMAH), Adrenocortical cancer, nonfunctioning adrenal tumor
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To build a registration system and a cohort for patients with adrenal tumors, 2) to produce new evidences of management of adrenal tumors contribute to clinical guidelines.
Basic objectives2
Others
Basic objectives -Others
To organize a multi-institutional study group,
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between clinical findings (baseline characteristics, hormonal data, imaging findings or treatments) and clinical course or prognosis.
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 who were diagnosed as pheochromocytoma, Cushing syndrome, subclinical Cushing syndrome, ACTH independent macronodular adrenal hyperplasia (AIMAH), adrenocortical cancer, and nonfunctioning adrenal tumor in department of diabetes, endocrinology and metabolism, national center for global health and medicine and collaborated institutes from Jan, 2006 to Dec, 2015.
Key exclusion criteria
Patients who were considered as unsuitable for this study.
Target sample size
1050
Research contact person
Name of lead principal investigator
| 1st name | Akiyo |
| Middle name | |
| Last name | Tanabe |
Organization
National Center for Global Health and Medicine
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
1628655
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo
TEL
03-3202-7181
atanabe@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Akiyo |
| Middle name | |
| Last name | Tanabe |
Organization
National Center for Global Health and Medicine
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
1628655
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
atanabe@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo
Tel
03-3202-7181
kenkyu-shinsa@hosp.ncgm.go.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 | 03 | Month | 11 | 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
| 2015 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 06 | 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
Observational study
Management information
Registered date
| 2016 | Year | 03 | Month | 11 | Day |
Last modified on
| 2022 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024726
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
