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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014720
Receipt No. R000017113
Scientific Title The efficacy evaluation of the human papillomavirus (HPV) testing in primary cervix cancer screening
Date of disclosure of the study information 2014/07/31
Last modified on 2015/05/26

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Basic information
Public title The efficacy evaluation of the human papillomavirus (HPV) testing in primary cervix cancer screening
Acronym The efficacy evaluation of the human papillomavirus (HPV) testing in primary cervix cancer screening
Scientific Title The efficacy evaluation of the human papillomavirus (HPV) testing in primary cervix cancer screening
Scientific Title:Acronym The efficacy evaluation of the human papillomavirus (HPV) testing in primary cervix cancer screening
Region
Japan

Condition
Condition Cervix cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to access efficacy of the human papillomavirus (HPV) testing for the primary cervical cancer screening over 7 years.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of CIN3 or worse during whole periods
Key secondary outcomes The incidence both of CIN3 and of CIN2 or worse during whole periods
The morbidity incidence rate of invasive cervical cancer, cumulative incidence of invasive cervical cancer
The frequency of examinations and accidental symptoms during whole periods

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Cervical cancer screening by using cytology testing alone as a standard screening modality(following up over 7 years)
Interventions/Control_2 Cervical cancer screening by using cytology testing plus HPV testing as an experimental screening modality(following up over 7 years)
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
30 years-old <=
Age-upper limit
49 years-old >=
Gender Female
Key inclusion criteria 1) Women aged 30-49 years old who have a screening of cervical cancer
2) Participants provided informed consent.
Key exclusion criteria 1)Women who have had invasive cervical cancer before.
2)Women who have underwent surgery of uterine cervix (cervical conization).
3)Women who have underwent hysterectomy.
4)Women who have had or have CIN or the cytological abnormalities and are under follow-up.
Target sample size 50000

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Daisuke Aoki
Organization School of Medicine, Keio University
Division name Department of Obstetrics and Gynecology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211(62391)
Email aoki@z7.keio.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yasuo Ohasi
Organization Japan Clinical Research Support Unit (J-CRSU)
Division name Clinical Research Call Center
Zip code
Address Ochanomizu-Kimura Bldg.4F 2-19-3 Sotokanda, Chiyoda-ku, Tokyo,101-0021 Japan
TEL 0120-717-411
Homepage URL http://square.umin.ac.jp/hpvt-study/
Email hpvtstudy-office@umin.org

Sponsor
Institute School of Medicine, Keio University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare (Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Japan Cancer Society, public interest foundation
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 34自治体に協力している検診実施機関

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 31 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 Open public recruiting
Date of protocol fixation
2014 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 08 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

Management information
Registered date
2014 Year 07 Month 31 Day
Last modified on
2015 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017113

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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