UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003150 |
|---|---|
| Receipt number | R000003823 |
| Scientific Title | Clinical research of HPV infection in head and neck squamous cell carcinoma |
| Date of disclosure of the study information | 2010/03/01 |
| Last modified on | 2022/09/29 08:10:33 |
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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
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
entmafuji@gmail.com
Sponsor or person
Institute
National Hospital Organization Tokyo Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003823
