UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027580 |
|---|---|
| Receipt number | R000031615 |
| Scientific Title | Measurement of galactose metabolites |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2024/06/05 15:11:30 |
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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
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
akikuchi-thk@umin.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
0
Results
Not applicable
Results date posted
| 2024 | Year | 06 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
None
Outcome measures
None
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Not applicable.
Management information
Registered date
| 2017 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031615
