UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research for gene identification of skeletal disorders
Title of the study (Brief title)	Study of Genetic Skeletal Disorders
Region	Japan

Condition
Condition	Skeletal disorders
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To identify causative genes of skeletal disorders
Basic objectives2	Others
Basic objectives -Others	To analyze genes of skeletal disorders
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Identification of causative genes of skeletal disorders
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	Patient and family
Key exclusion criteria	None
Target sample size	20

Research contact person
Name of lead principal investigator	Tomozumi Takatani
Organization	Chiba University Hospital
Division name	Pediatrics
Address	1-8-1 Inohana, Chuo-ku, Chiba, Chiba
TEL	043-222-7171
Email	t-takatani@chiba-u.jp

Public contact
Name of contact person	Tomozumi Takatani
Organization	Chiba University Hospital
Division name	Pediatrics
Address	1-8-1 Inohana, Chuo-ku, Chiba, Chiba
TEL	043-222-7171
Homepage URL
Email	t-takatani@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Center of Environmental Health Science for Future Generations
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 11 Month 18 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 11 Month 17 Day
Anticipated trial start date	2015 Year 11 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Genetic analysis

Management information
Registered date	2016 Year 11 Month 17 Day
Last modified on	2016 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028639