UMIN-CTR Clinical Trial

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
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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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