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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004785
Receipt No. R000005676
Scientific Title Efficacy of HPV vaccination in Japanese women
Date of disclosure of the study information 2011/02/01
Last modified on 2013/12/24

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Basic information
Public title Efficacy of HPV vaccination in Japanese women
Acronym Efficacy of HPV vaccination in Japanese women
Scientific Title Efficacy of HPV vaccination in Japanese women
Scientific Title:Acronym Efficacy of HPV vaccination in Japanese women
Region
Japan

Condition
Condition cervical cancer (intraepithelial neoplasia)
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of efficacy of HPV vaccine in Japanese women
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes cervical cancer, cervical intraepithelial neoplasia
Key secondary outcomes HPV infection

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
12 years-old <=
Age-upper limit
18 years-old >=
Gender Female
Key inclusion criteria HPV vaccination
Key exclusion criteria None
Target sample size 10000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Testu Takagi
Organization Osaka Sanfujinka Ikai
Division name OB/GYN
Zip code
Address 4-4-3 Kawaramachi, Chuo-ku, Osaka
TEL 06-6227-5383
Email osaka-og@aioros.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Enomoto
Organization Osaka University
Division name OB/GYN
Zip code
Address 2-2 Yamadaoka, SUita, Osaka
TEL 06-6879-3351
Homepage URL
Email enomoto@gyne.med.osaka-u.ac.jp

Sponsor
Institute Osaka Sanfujinka Ikai
Institute
Department

Funding Source
Organization Osaka Sanfujinka Ikai
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2011 Year 02 Month 01 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 Enrolling by invitation
Date of protocol fixation
2010 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cervical cytology and HPV infection will be evaluated when the participants become 20 and 25 years old.

Management information
Registered date
2010 Year 12 Month 24 Day
Last modified on
2013 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005676

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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