UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058597 |
|---|---|
| Receipt number | R000067001 |
| Scientific Title | CBG study |
| Date of disclosure of the study information | 2025/07/25 |
| Last modified on | 2025/07/25 15:53:34 |
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Basic information
Public title
Prospective observational study for corticosteroid binding globulin abnormality in patients with hypoadrenocorticism.
Acronym
A study for corticosteroid binding globulin abnormality
Scientific Title
CBG study
Scientific Title:Acronym
CBG study
Region
| Japan |
Condition
Condition
Hypoadrenocorticism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Impact of Abnormal Corticosteroid-Binding Globulin (CBG) on Adrenal Hormone Testing and Clinical Features in Patients with Hypoadrenocorticism
Basic objectives2
Others
Basic objectives -Others
Impact of Abnormal Corticosteroid-Binding Globulin (CBG) on Adrenal Hormone Testing and Clinical Features in Patients with Hypoadrenocorticism
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of CBG abnormality
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with suspected hypoadrenocorticism based on clinical symptoms and adrenal hormone tests in accordance with the treatment guidelines for hypoadrenocorticism. Healthy subjects who do not meet the exclusion criteria will be included.
Key exclusion criteria
1) Patients receiving exogenous steroids
2) Pregnant women
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Takeshima |
Organization
Wakayama Medical University
Division name
First Department of Internal Medicine
Zip code
641-8509
Address
811-1 Kimi-idera, Wakayama
TEL
073-447-2300
kt1094@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Takeshima |
Organization
Wakayama Medical University
Division name
First Department of Internal Medicine
Zip code
641-8509
Address
811-1 Kimi-idera, Wakayama
TEL
073-447-2300
Homepage URL
kt1094@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.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
| 2025 | Year | 07 | Month | 25 | 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
| 2023 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 07 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067001
