UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041331 |
|---|---|
| Receipt number | R000047194 |
| Scientific Title | Development of real-time PCR rapid diagnostic system for epidemic keratoconjunctivitis |
| Date of disclosure of the study information | 2020/08/10 |
| Last modified on | 2020/08/06 11:36:55 |
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Basic information
Public title
Development of real-time PCR rapid diagnostic system for epidemic keratoconjunctivitis
Acronym
Development of real-time PCR rapid diagnostic system for epidemic keratoconjunctivitis
Scientific Title
Development of real-time PCR rapid diagnostic system for epidemic keratoconjunctivitis
Scientific Title:Acronym
Development of real-time PCR rapid diagnostic system for epidemic keratoconjunctivitis
Region
| Japan |
Condition
Condition
epidemic keratoconjunctivitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Detection of HAdV with mobile PCR system from clinical samples
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of detection of HAdV with mobile PCR system from clinical samples
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were suspected EKC and tested using immunochromatography rapid diagnostic test for HAdV
Key exclusion criteria
none
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sujin |
| Middle name | |
| Last name | Hoshi |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennnoudai, Tsukuba City
TEL
0298533148
hoshisujin@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Sujin |
| Middle name | |
| Last name | Hoshi |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba City
TEL
0298533148
Homepage URL
hoshisujin@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
2-1-1 Amakubo, Tsukuba city
Tel
029-853-3914
t-credo.adm@un.tsukuba.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
| 2020 | Year | 08 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study.
case controlled study.
Discarded samples are used in this study.
Management information
Registered date
| 2020 | Year | 08 | Month | 06 | Day |
Last modified on
| 2020 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047194
