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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017663
Receipt No. R000020426
Scientific Title Gardasil vaccination for laryngeal papillomatosis.
Date of disclosure of the study information 2015/06/01
Last modified on 2019/03/18

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Basic information
Public title Gardasil vaccination for laryngeal papillomatosis.
Acronym Gardasil vaccination for laryngeal papillomatosis.
Scientific Title Gardasil vaccination for laryngeal papillomatosis.
Scientific Title:Acronym Gardasil vaccination for laryngeal papillomatosis.
Region
Japan

Condition
Condition laryngeal papillomatosis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study we carried out Gardasil vaccination in laryngeal papillomatosis. The purpose was to examine whether or not it effectively inhibited recurrence.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of recurrence
Key secondary outcomes Antibody value

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

Not applicable
Gender Male and Female
Key inclusion criteria HPV-6 or HPV-11 positive laryngeal papillomatosis.
Key exclusion criteria Laryngeal cancer.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Makiyama, MD PhD
Organization Nihon University Hospital
Division name Otorhinolaryngology
Zip code
Address 1-6 Kandasurugadai, Chiyoda, Tokyo 101-8309 Japan
TEL 03-3293-1711
Email mak@med.email.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoshi Makiyama, MD PhD
Organization Nihon University Hospital
Division name Otorhinolaryngology
Zip code
Address 1-6 Kandasurugadai, Chiyoda Tokyo 101-8309 Japan
TEL 03-3293-1711
Homepage URL
Email mak@med.email.ne.jp

Sponsor
Institute Otorhinolaryngology, Nihon University Hospital
Institute
Department

Funding Source
Organization Otorhinolaryngology, Nihon University Hospital
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
2015 Year 06 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 Completed
Date of protocol fixation
2011 Year 07 Month 01 Day
Date of IRB
2011 Year 07 Month 15 Day
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information The presence of the relapse is verified by the larynx fiber inspection.

Management information
Registered date
2015 Year 05 Month 25 Day
Last modified on
2019 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020426

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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