UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004785 |
|---|---|
| Receipt number | 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 09:08:41 |
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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
| Obstetrics 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
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
enomoto@gyne.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka Sanfujinka Ikai
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005676
