UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021572
Receipt number 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 18:43:57

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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 or person

Institute

The study group of basic research of the head and neck

Institute

Department

Personal name



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

Value
https://center6.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