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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019541
Receipt No. 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 2019/10/31

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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
Obsterics 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
Email 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
Email yterao@juntendo.ac.jp

Sponsor
Institute Juntendo Univ.Department of Obstetrics and Gynecology
Institute
Department

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
Email 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 No longer recruiting
Date of protocol fixation
2015 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 23 Day
Last follow-up date
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
2019 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022576

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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