UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038883 |
|---|---|
| Receipt number | 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 | 2022/12/14 11:10:30 |
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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
| Obstetrics 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
matsumok@mui.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Yamaguchi |
Organization
Showa University School of Medicine
Division name
Ethics Comittee
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8129
Homepage URL
m-rinri@ofc.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
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
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
22fk0108651h0001
Org. issuing International ID_2
Japan Agency for Medical Research and Dvelopment( AMED)
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
| 2022 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044259
| Research Plan | |
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| 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 |
