UMIN-CTR Clinical Trial

Basic information
Public title	The study on the patients with idiopathic basal ganglia calcification (IBGC) in Japan
Acronym	The study on the patients with IBGC in Japan
Scientific Title	The study on the patients with idiopathic basal ganglia calcification (IBGC) in Japan
Scientific Title:Acronym	The study on the patients with IBGC in Japan
Region	Japan

Condition
Condition	Idiopathic basal ganglia calcification (IBGC)
Classification by specialty	Neurology Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the cases of IBGC in Japan, based on the funding of Ministry of Health, Labor and Welfare.
Basic objectives2	Others
Basic objectives -Others	To survey for cases of IBGC in Japanese population. To search for headache in the patients with IBGC.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	To lay the foundation for future researches of IBGC.
Key secondary outcomes	To clarify the headache in the patients with IBGC status quo in Japan.

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	Conspicuous calcification is observed in the basal ganglia and/or dentate nucleus on CT scanning image. Calcification is bilateral and symmetrical. Idiopathic (absence of biochemical abnormalities, and an infections, toxic, or traumatic cause).
Key exclusion criteria	To exclude diseases which show calcification, because of some causes such as hypoparathyroism, pseudo hypoparathyroism, pseudopseudo hypoparathyroism (Albright's osteodystrophy), Down syndrome, collagen diseases, angiitis, infections, intoxication, trauma, radiation therapy and so on.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Isao Middle name Last name Hozumi
Organization	Gifu Pharmaceutical University
Division name	Laboratory of Medical Therapeutics and Molecular Therapeutics
Zip code	501-1196
Address	1-25-4 Daigaku-Nishi Gifu city, Gifu Prefecture, JAPAN 501-1196
TEL	058-230-8121
Email	hozumi@gifu-pu.ac.jp

Public contact
Name of contact person	1st name Isao Middle name Last name Hozumi
Organization	Gifu Pharmaceutical University
Division name	Laboratory of Medical Therapeutics and Molecular Therapeutics
Zip code	501-1196
Address	1-25-4 Daigaku-Nishi Gifu city, Gifu Prefecture, JAPAN 501-1196
TEL	058-230-8121
Homepage URL
Email	hozumi@gifu-pu.ac.jp

Sponsor
Institute	Gifu Pharmaceutical University
Institute
Department

Funding Source
Organization	Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)	Japan Agency for Medical Research and Development

IRB Contact (For public release)
Organization	Ethics Committee of Gifu Pharmaceutical University
Address	1-25-4 Daigakunishi Gifu, Gifu Prefecture, JAPAN
Tel	058-230-8100
Email	syomuk@gifu-pu.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	2015 Year 06 Month 08 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	300
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	Open public recruiting
Date of protocol fixation	2014 Year 11 Month 12 Day
Date of IRB	2014 Year 11 Month 12 Day
Anticipated trial start date	2014 Year 11 Month 12 Day
Last follow-up date	2024 Year 07 Month 31 Day
Date of closure to data entry	2024 Year 07 Month 31 Day
Date trial data considered complete	2024 Year 07 Month 31 Day
Date analysis concluded	2024 Year 07 Month 31 Day

Other
Other related information	To lay the foundation for future researches of IBGC. To clarify the headache in the patients with IBGC status quo in Japan.

Management information
Registered date	2015 Year 06 Month 04 Day
Last modified on	2019 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020635

Research Plan
Registered date	File name
2019/11/12	疫学研究計画書.docx

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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