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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027580
Receipt No. R000031615
Scientific Title Measurement of galactose metabolites
Date of disclosure of the study information 2017/06/01
Last modified on 2019/06/02

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Basic information
Public title Measurement of galactose metabolites
Acronym Measurement of galactose metabolites
Scientific Title Measurement of galactose metabolites
Scientific Title:Acronym Measurement of galactose metabolites
Region
Japan

Condition
Condition hypergalactosemia
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To measure galactose metabolites in the blood from patients with hypergalactosemia or healthy individuals (patients with non-hypergalactosemia)
Basic objectives2 Others
Basic objectives -Others As described above
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To compare between galactose metabolites in the blood from patients with hypergalactosemia and those from healthy individuals (patients with non-hypergalactosemia)
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
1 days-old <=
Age-upper limit
21915 days-old >
Gender Male and Female
Key inclusion criteria Patients with hypergalactosemia and their family members
Healthy volunteers and patients with diseases except for hypergalactosemia
Key exclusion criteria Participants in other interventional studies
Persons who are not suitable for this study for any reasons
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Kure
Middle name
Last name Shigeo
Organization Tohoku University Graduate School of Medicine
Division name Department of Pediatrics
Zip code 980-8574
Address 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-7287
Email kure@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Kikuchi
Middle name
Last name Atsuo
Organization Tohoku University Hospital
Division name Department of Pediatrics
Zip code 980-8574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-7287
Homepage URL
Email akikuchi-thk@umin.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Self funding
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 Tohoku University
Address 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel 022-717-8007
Email med-kenkyo@grp.tohoku.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
2017 Year 06 Month 01 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 25 Day
Date of IRB
2017 Year 05 Month 29 Day
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not applicable.

Management information
Registered date
2017 Year 05 Month 31 Day
Last modified on
2019 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031615

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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