UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049612 |
|---|---|
| Receipt number | R000056432 |
| Scientific Title | Analysis of genes related to the onset of endocrine metabolic diseases |
| Date of disclosure of the study information | 2022/11/28 |
| Last modified on | 2022/11/25 16:04:22 |
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Basic information
Public title
Analysis of genes related to the onset of endocrine metabolic diseases
Acronym
Analysis of genes related to the onset of endocrine metabolic diseases
Scientific Title
Analysis of genes related to the onset of endocrine metabolic diseases
Scientific Title:Acronym
Analysis of genes related to the onset of endocrine metabolic diseases
Region
| Japan |
Condition
Condition
endocrine disease and metabolic disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To discover the responsible genes and disease-related genes of endocrine and metabolic diseases.
Basic objectives2
Others
Basic objectives -Others
To elucidate the pathophysiology and causes of individual patients' diseases.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To discover genes responsible for endocrine metabolic diseases and disease-related genes.
Key secondary outcomes
To elucidate the pathophysiology and causes of individual patient diseases.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Take an additional 20 ml of blood at the same time as the blood test
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who visited our outpatient department and were diagnosed with an endocrine metabolic disease
Among them, patients for whom genetic abnormalities were not evident even after conducting tests for gene mutations that can be tested at the time of research protocol creation
2)Patients aged 16 years or older at the time of informed consent
3)regardless gender
4)Patients who obtained written consent from the patient's own free will or proxy consent after receiving sufficient explanation about participating in this study
Key exclusion criteria
Patients who are judged to be inappropriate as research subjects by the investigator (co-investigator)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Ohta |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Endocrinology, Metabolism, Hematological Science and Therapeutics
Zip code
755-8505
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL
0836-22-2251
yohta@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Nagao |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Endocrinology, Metabolism, Hematological Science and Therapeutics
Zip code
755-8505
Address
1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL
0836-22-2251
Homepage URL
ynagao@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate School of 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
Yamaguchi University Graduate School of Medicine
Address
1-1-1 Minami-koguchi, Ube, Yamaguchi
Tel
0836-22-2251
ynagao@yamaguchi-u.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
| 2022 | Year | 11 | Month | 28 | 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
| 2021 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 25 | Day |
Last modified on
| 2022 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056432
