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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051858


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name