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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009794
Receipt No. R000011474
Scientific Title Evaluation of immunochromatography test kit in genital chlamydia infections rapid test.
Date of disclosure of the study information 2013/02/01
Last modified on 2016/01/20

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Basic information
Public title Evaluation of immunochromatography test kit in genital chlamydia infections rapid test.
Acronym Evaluation of rapid diagnostic test.
Scientific Title Evaluation of immunochromatography test kit in genital chlamydia infections rapid test.
Scientific Title:Acronym Evaluation of rapid diagnostic test.
Region
Japan

Condition
Condition Sexually transmitted infections
Classification by specialty
Obsterics and gynecology Laboratory medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of immunochromatography test kit in genitalchlamydialinfections
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Compare performance of the new test kit with the traditional one, and evaluate the usefulness in clinical testing.
1)Evaluate the correlation between the new kit and traditional tests.
2)Evaluate the usefulness of the handling and the rapidity.
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 Female
Key inclusion criteria 1)Suffers from sexually transmitted infections.
2)Getting the agreement of the clinical evaluation from patients or her agents.
Key exclusion criteria 1)Typical symptom(i.e. yoghurt like secretion) is appeared clearly and is not need the diagnosis to use the test kit.
2)Patient for whom a clinical followup and a clear final diagnosis are judged to be difficult.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhisa Terao
Organization Juntendo University
Division name Obstetrics and Gynecology
Zip code
Address 2-1-1 Hongo,Bunkyo Tokyo
TEL 03-3813-3111
Email yterao@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhisa Terao
Organization Juntendo University
Division name Obstetrics and Gynecology
Zip code
Address 2-1-1,Hongo,Bunkyo Tokyo
TEL 03-3813-3111
Homepage URL
Email yterao@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kanto Chemical Co.,Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 02 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
2013 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 07 Month 22 Day

Other
Other related information Compare the new test kit with traditional one, the former should be rapid than latter, and correlate with the latter.

Management information
Registered date
2013 Year 01 Month 17 Day
Last modified on
2016 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011474

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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