UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045419 |
|---|---|
| Receipt number | R000051858 |
| Scientific Title | Investigation of the preventive effect of HPV vaccination against oral HPV infection |
| Date of disclosure of the study information | 2021/09/08 |
| Last modified on | 2021/09/08 12:56:13 |
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Basic information
Public title
Investigation of the preventive effect of HPV vaccination against oral HPV infection
Acronym
Investigation of oral HPV infection
Scientific Title
Investigation of the preventive effect of HPV vaccination against oral HPV infection
Scientific Title:Acronym
Study of HPV vaccination effectiveness against oral HPV infection
Region
| Japan |
Condition
Condition
oropharyngeal cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the status of oral HPV infection in Japanese people and analyze the preventive effect of HPV vaccination against oral HPV infection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
oral HPV infection rate
Key secondary outcomes
vaccine effectiveness against oral 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
| 20 | years-old | <= |
Age-upper limit
| 26 | years-old | >= |
Gender
Female
Key inclusion criteria
Women aged 20-26 attending public cervical cancer screening in Niigata city
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Sekine |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Obstetrics and Gynecology
Zip code
951-8510
Address
1-757, Asahimachi-Dori, Chuo-ku, Niigata
TEL
0252272320
masa@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Kurosawa |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Obstetrics and Gynecology
Zip code
951-8510
Address
1-757, Asahimachi-Dori, Chuo-ku, Niigata
TEL
0252272320
Homepage URL
m-kurosawa@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology,
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University Graduate School of Medical and Dental Sciences
Address
1-757, Asahimachi-Dori, Chuo-ku, Niigata
Tel
0252272625
niigata@esct.bvits.com
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
新潟大学大学院医歯学総合研究科
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 08 | 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
| 2020 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
| 2025 | Year | 06 | Month | 15 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 15 | Day |
Date analysis concluded
| 2025 | Year | 06 | Month | 15 | Day |
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 09 | Month | 08 | Day |
Last modified on
| 2021 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051858
