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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038883
Receipt No. R000044259
Scientific Title Study for Monitoring the Impact of National HPV vaccinaTion program in Japan( Period II: April 2019-December 2026)
Date of disclosure of the study information 2019/12/16
Last modified on 2019/12/13

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Basic information
Public title Study for Monitoring the Impact of National HPV vaccinaTion program in Japan( Period II : April 2019-December 2026)
Acronym Monitoring the Impact of National HPV vaccinaTion program in Japan (MINT study II )
Scientific Title Study for Monitoring the Impact of National HPV vaccinaTion program in Japan( Period II: April 2019-December 2026)
Scientific Title:Acronym Monitoring the Impact of National HPV vaccinaTion program in Japan (MINT study II )
Region
Japan

Condition
Condition Cervical cancer and its precursor lesions
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Monitoring the Impact of National HPV vaccination program in Japan
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The proportion of HPV16/18 positives among subjects of
cervical cancer, CIN2/3 and AIS in women aged 16-24, and 25-29 years
Key secondary outcomes 1. The number of women aged 16-24, and 25-29 years who contract cervical cancer,CIN2/3, AIS
2. The proportion of HPV16/18 positives among subjects of CIN1 in women aged 16-24, and 25-29 years
3. The proportion of HPV16/18 positives among subjects of cervical cancer, CIN2/3 and AIS in women aged 16-39 years
4. The distribution of HPV types among subjects of cervical cancer, CIN1/2/3, and AIS in women aged 16-39 years
5. The number of women aged 16-39 years who contract cervical cancer, CIN2/3, and AIS
6. The proportion of HPV16/18 positives among women aged 16-39 years with CIN1
7. The number of deaths from cervical cancer among women aged 16-39 years

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
16 years-old <=
Age-upper limit
40 years-old >
Gender Female
Key inclusion criteria All females, aged 16-39 years, who are newly diagnosed with cervical cancer, CIN, or AIS and have not yet been treated
Key exclusion criteria Individuals in either of the groups listed below will be excluded as subjects of the research
1. Female patients younger than 16 or older than 39 years
2. Female who do not have CIN, AIS or cervical cancer
Target sample size 4000

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Matsumoto
Organization Showa University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code 142-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8551
Email matsumok@mui.biglobe.ne.jp

Public contact
Name of contact person
1st name Mamiko
Middle name
Last name Onuki
Organization Showa University School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code 142-8666
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8551
Homepage URL
Email monuki@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Dvelopment( AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Showa University School of Medicine
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel 03-3784-8551
Email monuki@med.showa-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 19fk0108098
Org. issuing International ID_1 Japan Agency for Medical Research and Dvelopment( AMED)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 16 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
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 07 Month 16 Day
Anticipated trial start date
2019 Year 07 Month 25 Day
Last follow-up date
2026 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Proactive long-term epidemiological joint research conducted at multiple facilities

Management information
Registered date
2019 Year 12 Month 13 Day
Last modified on
2019 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044259

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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