UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020055 |
|---|---|
| Receipt number | R000022510 |
| Scientific Title | Tests of cytomegalovirus fetomaternal infection |
| Date of disclosure of the study information | 2015/12/03 |
| Last modified on | 2021/06/11 05:15:01 |
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Basic information
Public title
Tests of cytomegalovirus fetomaternal infection
Acronym
Tests of cytomegalovirus fetomaternal infection
Scientific Title
Tests of cytomegalovirus fetomaternal infection
Scientific Title:Acronym
Tests of cytomegalovirus fetomaternal infection
Region
| Japan |
Condition
Condition
Cytomegalovirus fetomaternal infection
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We perform cytomegalovirus antibody test, viral nucleic acid test, and viral isolation test of infected mothers and congenitally infected babies.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Duration of cytomegalovus(CMV)IgM, low IgG avidity, CMV nucleic acid, and CMV isolation
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
infected mother with consent
Key exclusion criteria
congenitally infected baby from infected mother with mother's consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Ikeda |
Organization
Mie University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie
TEL
059-232-1111
t-kuniaki@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Kuniaki |
| Middle name | |
| Last name | Toriyabe |
Organization
Mie University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie
TEL
059-232-1111
Homepage URL
to.kuniaki@gmail.com
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Mie 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
the Clinical Research Ethics Review Committee of the Mie University Hospital
Address
2-174 Edobashi, Tsu, Mie
Tel
059-232-1111
kk-sien@mo.medic.mie-u.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
三重大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:cohort study
Recruitment plan:patients matching for the criteria from December 2015
Measurement items:Cytomegalovirus(CMV)IgM, IgG avidity, CMV DNA, and CMV isolation
Management information
Registered date
| 2015 | Year | 12 | Month | 03 | Day |
Last modified on
| 2021 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022510
| Research Plan | |
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| 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 |
