UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research of HPV infection in head and neck squamous cell carcinoma
Acronym	HPV infection in head and neck cancer
Scientific Title	Clinical research of HPV infection in head and neck squamous cell carcinoma
Scientific Title:Acronym	HPV infection in head and neck cancer
Region	Japan

Condition
Condition	Head and neck squamous cell carcinoma
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To clarify how HPV involved in head and neck cancer To clarify relationship between HPV infection and clinical prognosis To find the usefulness of brushing examination for HPV detection To perform HPV genotyping in head and neck cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Prevalence of HPV infection Association between HPV infection and clinical factors Detection rate of brushing examination for HPV infection
Key secondary outcomes

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients diagnosed oropharyngeal squamous cell carcinoma by pathological examination The patients over 12 years old who underwent tonsillectomy due to habitual tonsillitis or hypertrophy of tonsil
Key exclusion criteria	Nothing in particular
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name Fujii
Organization	Eiju General Hospital
Division name	Department of Otorarhingology
Zip code	1108645
Address	2-23-16 Higashiueno Taitouku Tokyo Japan
TEL	03-3833-8381
Email	entmafuji@gmail.com

Public contact
Name of contact person	1st name Masato Middle name Last name Fujii
Organization	Eiju General Hospital
Division name	Otolaryngology
Zip code	1108645
Address	2-23-16 Higashiueno Taitouku Tokyo Japan
TEL	03-383-8381
Homepage URL
Email	entmafuji@gmail.com

Sponsor
Institute	National Hospital Organization Tokyo Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Tokyo Medical Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Society of basic research for head and neck cancer
Name of secondary funder(s)	Research Center

IRB Contact (For public release)
Organization	NTMC
Address	Meguro Tokyo Japan
Tel	03-3411-0111
Email	entmafuji@gmail.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

Other administrative information
Date of disclosure of the study information	2010 Year 03 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 02 Month 27 Day
Date of IRB
Anticipated trial start date	2010 Year 03 Month 01 Day
Last follow-up date	2011 Year 04 Month 01 Day
Date of closure to data entry	2011 Year 09 Month 01 Day
Date trial data considered complete	2011 Year 12 Month 01 Day
Date analysis concluded	2012 Year 03 Month 01 Day

Other
Other related information	Weclarify how HPV involved in head and neck cancer. Patients with oropharygeal cancer is enrolled. We clarify the relationship between HPV infection and clinical prognosis. We perform HPV genotyping in head and neck cancer. The normal tosil wil be also examined.

Management information
Registered date	2010 Year 02 Month 08 Day
Last modified on	2022 Year 09 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003823