UMIN-CTR Clinical Trial

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
Email	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
Email	m-kurosawa@med.niigata-u.ac.jp

Sponsor
Institute	Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051858