UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016839 |
|---|---|
| Receipt number | R000019549 |
| Scientific Title | Exploratory study for concurrent testing of cervical cytology, high-risk HPV and Chlamydia trachomatis from liquid based cytology. |
| Date of disclosure of the study information | 2015/03/25 |
| Last modified on | 2016/03/22 09:55:23 |
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Basic information
Public title
Exploratory study for concurrent testing of cervical cytology, high-risk HPV and Chlamydia trachomatis from liquid based cytology.
Acronym
Concurrent testing of cervical cytology, high-risk HPV and Chlamydia trachomatis.
Scientific Title
Exploratory study for concurrent testing of cervical cytology, high-risk HPV and Chlamydia trachomatis from liquid based cytology.
Scientific Title:Acronym
Concurrent testing of cervical cytology, high-risk HPV and Chlamydia trachomatis.
Region
| Japan |
Condition
Condition
Cervical cytology, Sexual transmitted Infection
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the possible association between cervical cytology, high-risk HPV and Chlamydia trachomatis.
Basic objectives2
Others
Basic objectives -Others
association
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between cervical cytology results and Chlamydia trachomatis and association between high-risk HPV and Chlamydia trachomatis.
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
| Not applicable |
Gender
Female
Key inclusion criteria
Woman aged 20 years or older
Woman whom underwent a cervical cancer screening
Woman whom underwent a sexually transmitted infection screening
Key exclusion criteria
Woman who is pregnant
Woman who has a risk for taking a specimen
Woman who has difficulty to get the informed consent
Woman whom the investigator judged as inappropriate as a subject of this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Noguchi |
Organization
Aichi Medical University Hospital
Division name
Department Of Obstetrics and Gynecology
Zip code
Address
1-1, Yazakokarimata, Nagakute,Aichi
TEL
0561-62-3311
yasuyuki@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shusaku Tozaka |
Organization
Nippon Becton Dickinson Company, Ltd
Division name
Medical Affairs
Zip code
Address
15-1,Akasaka 4-chome,Minato-ku,Tokyo
TEL
03-6234-5628
Homepage URL
shusaku_tozaka@bd.com
Sponsor or person
Institute
Aichi Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Becton Dickinson Company, Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hoshina clinic
Tsushima ruriko women's life science clinic Ginza
Ihc Omotesando
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
| 2015 | Year | 03 | Month | 25 | 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
| 2015 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 15 | Day |
Other
Other related information
Both high-risk HPV and Chlamydia trachomatis are sexual transmitted infection. If association of cervical cytology results, Chlamydia trachomatis infection and high-risk HPV are shown, significance of concurrent testing may be found.
Management information
Registered date
| 2015 | Year | 03 | Month | 19 | Day |
Last modified on
| 2016 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019549
