UMIN-CTR Clinical Trial

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
Email	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
Email	ynagao@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056432