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

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 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


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

Value
https://center6.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