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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025977
Receipt No. R000029860
Scientific Title The trial to induction the human papillomavirus (HPV) testing into cervical cancer screening in Fukui prefecture, Japan
Date of disclosure of the study information 2017/02/06
Last modified on 2017/02/02

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Basic information
Public title The trial to induction the human papillomavirus (HPV) testing into cervical cancer screening in Fukui prefecture, Japan
Acronym FCCS (Fukui Cervical Cancer Screening) study
Scientific Title The trial to induction the human papillomavirus (HPV) testing into cervical cancer screening in Fukui prefecture, Japan
Scientific Title:Acronym FCCS (Fukui Cervical Cancer Screening) study
Region
Japan

Condition
Condition uterine cervical cancer
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective is to determine whether the introduction of HPV testing into cervical cancer screening make sensitivity improve in Japan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The sensitivities for cervical intraepithelial neoplasia (CIN) 2 or worse on cytology, HPV testing, and cotesting with cytology and HPV testing
Key secondary outcomes The prevalence of high-risk HPV, HPV16 genotype and HPV18 genotype by age group

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 biopsy
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
25 years-old <=
Age-upper limit
69 years-old >=
Gender Female
Key inclusion criteria Participants were recruited from among women aged 25 to 69 years, who participated in cervical cancer screening programs from eight cities in Fukui prefecture between May 2015 and March 2016.
Key exclusion criteria absent uterus, treatment or follow-up of CIN, pregnant women
Target sample size 14000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshida Yoshio
Organization University of Fukui
Division name Department of Obstetrics and Gynecology
Zip code
Address 23-3 Matsuoka, Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL +81-776-61-8392
Email yyoshida@u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuji Kurokawa
Organization University of Fukui
Division name Department of Obstetrics and Gynecology
Zip code
Address 23-3 Matsuoka, Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL +81-776-61-8392
Homepage URL
Email kurotetu@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

Funding Source
Organization Roche Diagnostics K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2017 Year 02 Month 06 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 No longer recruiting
Date of protocol fixation
2014 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 02 Day
Last modified on
2017 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029860

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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