UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052687 |
|---|---|
| Receipt number | R000060121 |
| Scientific Title | Establishment of a medical data registry to improve the quality of medical care for endocrine and metabolic diseases and the validity of diagnosis and treatment. |
| Date of disclosure of the study information | 2023/11/06 |
| Last modified on | 2023/11/02 19:53:03 |
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Basic information
Public title
Establishment of a medical data registry to improve the quality of medical care for endocrine and metabolic diseases and the validity of diagnosis and treatment.
Acronym
Endocrine Metabolism Registry Study
Scientific Title
Establishment of a medical data registry to improve the quality of medical care for endocrine and metabolic diseases and the validity of diagnosis and treatment.
Scientific Title:Acronym
Endocrine Metabolism Registry Study
Region
| Japan |
Condition
Condition
Diabetes, obesity, thyroid/parathyroid disease, adrenal disease, hypothalamic/pituitary disease, neuroendocrine disease, gonadal disease, and other endocrine disorders (including ectopic hormone-producing diseases)
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to improve the quality of medical care for endocrine and metabolic diseases at our university by creating a medical data registry using the medical data of patients with endocrine and metabolic diseases at our university.
Basic objectives2
Others
Basic objectives -Others
Analyzing the usefulness of current tests, the validity of current diagnostic methods, and the impact of treatment methods on prognosis, and providing feedback for better medical care and treatment planning. We also aim to improve the quality of medical care for endocrine and metabolic diseases at our university. In addition, we will disseminate such evidence and apply it to practice guidelines and other guidelines.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The aim of this study is to register data for a registry study.
Based on the registered data, we will analyze the usefulness of tests, the validity of current diagnostic methods, and the prognostic impact of treatment methods.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are inpatients or outpatients at the hospital for close examination or treatment of the target disease and who have given their consent to participate in this study.
Key exclusion criteria
Patients who are unable to give written consent or who are deemed by the physician in charge to be unsuitable for this study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Sone |
| Middle name | |
| Last name | Masakatsu |
Organization
St.Marianna University of Medicine Hospital
Division name
Endocrinology and Metabolism.
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
0449778111
h2tsukiyama@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Sone |
| Middle name | |
| Last name | Masakatsu |
Organization
St. Marianna University School of Medicine
Division name
Endocrinology and Metabolism.
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
0449778111
Homepage URL
taishanaika-001@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
St. Marianna University Bioethics Committee
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
Tel
0449778111
marianna@esct.bvits.com
Secondary IDs
Secondary IDs
YES
Study ID_1
5993
Org. issuing International ID_1
St. Marianna University Bioethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Registry Studies
Management information
Registered date
| 2023 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060121
