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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021572
Receipt No. R000024875
Scientific Title Biomarker research on the association between the effect and the HPV infection on the multimodal therapy for oropharyngeal squamous cell carcinoma
Date of disclosure of the study information 2016/03/23
Last modified on 2019/06/06

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Basic information
Public title Biomarker research on the association between the effect and the HPV infection on the multimodal therapy for oropharyngeal squamous cell carcinoma
Acronym Biomarker research on the HPV infection for oropharyngeal carcinoma
Scientific Title Biomarker research on the association between the effect and the HPV infection on the multimodal therapy for oropharyngeal squamous cell carcinoma
Scientific Title:Acronym Biomarker research on the HPV infection for oropharyngeal carcinoma
Region
Japan

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

Objectives
Narrative objectives1 We research an association between the effect of the oropharyngeal squamous cell carcinoma and the HPV infection on the chemoradiotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The efficacy of multimodal therapy and HPV infection for oropharyngeal carcinoma
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Gene
Interventions/Control_1 chemotherapy, chemoradiotherapy
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria oropharyngeal squamous cell carcinoma
Stage III/IV
PS 0,1
No prior treatment
Key exclusion criteria Patient with surgical treatment
Distant metastasis
Double cancer
Target sample size 213

Research contact person
Name of lead principal investigator
1st name Katsunari
Middle name
Last name Yane
Organization Kindai University Nara Hospital
Division name Otorhinolaryngology
Zip code 630-0293
Address 1248-1,Otoda,Ikoma,nara
TEL 0743-77-0880
Email kyane@med.kindai.ac.jp

Public contact
Name of contact person
1st name Katsunari
Middle name
Last name Yane
Organization Kindai University Nara Hospital
Division name Otorhinolaryngology
Zip code 630-0293
Address 1248-1,Otoda,Ikoma,nara
TEL 0743-77-0880
Homepage URL
Email kyane@med.kindai.ac.jp

Sponsor
Institute The study group of basic research of the head and neck
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kindai University Nara Hospital
Address 1248-1,Otoda,Ikoma,nara
Tel 0743-77-0880
Email ikyokujimu@med.kindai.ac.jp

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
2016 Year 03 Month 23 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 Open public recruiting
Date of protocol fixation
2015 Year 10 Month 01 Day
Date of IRB
2015 Year 11 Month 30 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information Accompanying study of UMIN000013476

Management information
Registered date
2016 Year 03 Month 22 Day
Last modified on
2019 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024875

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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