UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014720 |
|---|---|
| Receipt number | 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 22:38:25 |
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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
| Obstetrics 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
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)
aoki@z7.keio.jp
Public contact
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/
hpvtstudy-office@umin.org
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017113
| 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 |
