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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008891
Receipt No. R000010431
Scientific Title Monitoring the Impact of National HPV vaccinaTion program in Japan (MINT study) -Following the Commencement of a Publicly Funded HPV Vaccine Project for Adolescent Females- (Period I: April 2012 - December 2019)
Date of disclosure of the study information 2012/09/11
Last modified on 2012/09/12

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Basic information
Public title Monitoring the Impact of National HPV vaccinaTion program in Japan (MINT study) -Following the Commencement of a Publicly Funded HPV Vaccine Project for Adolescent Females- (Period I: April 2012 - December 2019)
Acronym Monitoring the Impact of National HPV vaccinaTion program in Japan (MINT study)
Scientific Title Monitoring the Impact of National HPV vaccinaTion program in Japan (MINT study) -Following the Commencement of a Publicly Funded HPV Vaccine Project for Adolescent Females- (Period I: April 2012 - December 2019)
Scientific Title:Acronym Monitoring the Impact of National HPV vaccinaTion program in Japan (MINT study)
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 HPV 16/18 positives among subjects of cervical cancer, grades 2/3 CIN (CIN 2/3) and AIS in women aged 16-25
Key secondary outcomes 1. The number of women aged 16-25 who contract cervical cancer, CIN 2/3, AIS
2. The proportion of HPV 16/18 positives among women aged 16-25 with CIN 1
3. The proportion of HPV 16/18 positives among subjects of cervical cancer, CIN 2/3 and AIS in women aged 16-39
4. The distribution of types of HPV among subjects of cervical cancer, CIN 1, CIN 2/3 and AIS in women aged 16-39
5. The number of women aged 16-39 who contract cervical cancer, CIN 2/3, AIS
6. The proportion of HPV 16/18 positives among women aged 16-39 with CIN 1
7. The number of deaths from cervical cancer among women aged 16-39

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, who are newly diagnosed with cervical cancer, CIS 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 this research
1. Female patients younger than 16 or older than 39
2. Females who do not have CIN 1, CIN 2/3, AIS or cervical cancer
Target sample size 4000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Yoshikawa
Organization University of Tsukuba
Division name Department of Obstetrics and Gynecology, Faculty of Medicine
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-3049
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koji Matsumoto
Organization University of Tsukuba
Division name Department of Obstetrics and Gynecology, Faculty of Medicine
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-3073
Homepage URL
Email matsumok@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Foundation for Advancement of International Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2012 Year 09 Month 11 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
2012 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 08 Day
Last follow-up date
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
2012 Year 09 Month 11 Day
Last modified on
2012 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010431

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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