UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009794 |
|---|---|
| Receipt number | 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 10:52:02 |
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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
| Obstetrics 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
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
yterao@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011474
