UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008891 |
|---|---|
| Receipt number | 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 22:31:39 |
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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
| 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 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
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
matsumok@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010431
