UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043462 |
|---|---|
| Receipt number | R000049631 |
| Scientific Title | Prenatal diagnosis of mucolipidosis II using fetal cells in amniotic fluid |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2022/03/01 11:43:31 |
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Basic information
Public title
Prenatal diagnosis of mucolipidosis II using fetal cells in amniotic fluid
Acronym
Prenatal diagnosis of mucolipidosis II using fetal cells in amniotic fluid
Scientific Title
Prenatal diagnosis of mucolipidosis II using fetal cells in amniotic fluid
Scientific Title:Acronym
Prenatal diagnosis of mucolipidosis II using fetal cells in amniotic fluid
Region
| Japan |
Condition
Condition
Mucolipidosis II
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To diagnose mucolipidosis II using fetal cells in amniotic fluid
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
whether fetus will be affected or not
Key secondary outcomes
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
Prevention
Type of intervention
| Gene |
Interventions/Control_1
PCR and direct sequencing of the affected gene (GNPT) and indirect diagnosis using microsatellite analysis or Karyomapping
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
Female
Key inclusion criteria
Pregnant woman who previously delivered the baby with mucolipidosis II
Key exclusion criteria
nothing
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Baba |
Organization
Sapporo Medical University
Division name
Obstetrics and Gynecology
Zip code
060-8543
Address
South 1 West 16, Sapporo, Hokkaido
TEL
0116112111
tbaba@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Baba |
Organization
Sapporo Medical University
Division name
Obstetrics and Gynecology
Zip code
0608543
Address
South 1 West 16, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
tbaba@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
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
Institutional review board at Sapporo Medical University
Address
South 1 West 16, Sapporo, Hokkaido
Tel
011-611-2111
ji-rskk@sapmed.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
| 2021 | Year | 03 | 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
1
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
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 28 | Day |
Last modified on
| 2022 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049631
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
