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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016839
Receipt No. 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

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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
Obsterics 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
Email 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
Email shusaku_tozaka@bd.com

Sponsor
Institute Aichi Medical University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019549

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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