UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025977 |
|---|---|
| Receipt number | 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 | 2024/02/08 14:24:30 |
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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
| Obstetrics 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 | Yoshio |
| Middle name | |
| Last name | Yoshida |
Organization
University of Fukui
Division name
Department of Obstetrics and Gynecology
Zip code
9101193
Address
23-3 Matsuoka, Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
0776618392
kurotetu@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuji |
| Middle name | |
| Last name | Kurokawa |
Organization
University of Fukui
Division name
Department of Obstetrics and Gynecology
Zip code
9101193
Address
23-3 Matsuoka, Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
0776618392
Homepage URL
kurotetu@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
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
University of Fukui
Address
23-3, Matsuoka-Shimoaitsuki, Eiheiji-Cho, Yoshida-Gun,
Tel
0776613111
rinrisys@ml.u-fukui.ac.jp
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
https://fukui.bvits.com/rinri/Common/
Publication of results
Unpublished
Result
URL related to results and publications
https://fukui.bvits.com/rinri/Common/
Number of participants that the trial has enrolled
7585
Results
The purpose of the FCCS study (Fukui Cervical Cancer Screening study), which is a clinical study introduced into preventive cervical cancer screening in Fukui Prefecture, is to propose an ideal screening method (a screening with a good balance between benefits and disadvantages). The FCCS study data that we reported alone cannot determine the timing of introducing HPV testing into screening, or whether screening intervals can be extended by introducing HPV testing, but it can be used as a reference.
Results date posted
| 2024 | Year | 02 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Women aged 25-69 who participated in uterine cervical cancer screening in Fukui Prefecture
Participant flow
Obtain a consent form when participating in cervical cancer and participate in the study
Adverse events
None
Outcome measures
Changes in cervical cancer detection rate due to the introduction of HPV testing in uterine cervical cancer screening
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
| 2014 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029860
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
