UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019541 |
|---|---|
| Receipt number | R000022576 |
| Scientific Title | Research and development of nucleic acid detection pretreatment methods that contribute to the infection diagnosis and treatment of Obstetrics and Gynecology |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2022/06/20 10:40:17 |
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Basic information
Public title
Research and development of nucleic acid detection pretreatment methods that contribute to the infection diagnosis and treatment of Obstetrics and Gynecology
Acronym
Research and development of nucleic acid detection pretreatment methods that contribute to the infection diagnosis and treatment of Obstetrics and Gynecology
Scientific Title
Research and development of nucleic acid detection pretreatment methods that contribute to the infection diagnosis and treatment of Obstetrics and Gynecology
Scientific Title:Acronym
Research and development of nucleic acid detection pretreatment methods that contribute to the infection diagnosis and treatment of Obstetrics and Gynecology
Region
| Japan |
Condition
Condition
infection
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of detection pre-processing method and the detection reagent that contribute to the infection diagnosis and treatment
Basic objectives2
Others
Basic objectives -Others
Reagent development
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The effectiveness of the pre-treatment method
Key secondary outcomes
The effectiveness of the nucleic acid detection reagents
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
In addition to the specimen collection in the normal inspection, to collect the specimen.1 subject once.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Department of Obstetrics and Gynecology outpatient visits
Key exclusion criteria
under 20
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Terao |
Organization
Juntendo Univ.
Division name
Department of Obstetrics and Gynecology
Zip code
113-8421
Address
Tokyo Hongo, Bunkyo-ku, 2-1-1
TEL
03-3813-3111-3365
yterao@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Terao |
Organization
Juntendo Univ.
Division name
Department of Obstetrics and Gynecology
Zip code
113-8421
Address
Tokyo Hongo, Bunkyo-ku, 2-1-1
TEL
03-3813-3111-3365
Homepage URL
yterao@juntendo.ac.jp
Sponsor or person
Institute
Juntendo Univ.Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Juntendo Univ.Department of Obstetrics and Gynecology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
juntendo Hospital IRB
Address
Tokyo Hongo, Bunkyo-ku, 2-1-1
Tel
03-5802-1584
kenkyu5858@juntendo.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
| 2016 | Year | 04 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 28 | Day |
Last modified on
| 2022 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022576
