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Recruitment status Completed
Unique ID issued by UMIN UMIN000006786
Receipt No. R000008031
Scientific Title Evaluation of new immunochromatography rapid test for detecting candidasis
Date of disclosure of the study information 2011/11/28
Last modified on 2012/05/29

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Basic information
Public title Evaluation of new immunochromatography rapid test for detecting candidasis
Acronym Evaluation of immunochromatography test for detecting candidasis
Scientific Title Evaluation of new immunochromatography rapid test for detecting candidasis
Scientific Title:Acronym Evaluation of immunochromatography test for detecting candidasis
Region
Japan

Condition
Condition Vaginal candidasis
Classification by specialty
Obsterics and gynecology Laboratory medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of New Immunochromato-
graphy test for diagnosis performance in candidosis patients.
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 for handling.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1)Suffers from candidosis
2)Getting the agreement of the clinical evaluation from patients or
His 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 is obviously suspected to be bacterial vaginitis.
3)Patient for whom a clinical follow-
up and a clear final diagnosis are judged to be difficult.
Target sample size 50

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
Email

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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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

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

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
2011 Year 11 Month 28 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
2011 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date
2011 Year 11 Month 28 Day
Last modified on
2012 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008031


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