UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029172
Receipt number R000033350
Scientific Title A study related to the risk factors and their proliferation of head, neck and esophageal cancers
Date of disclosure of the study information 2017/12/01
Last modified on 2021/09/20 12:33:04

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Basic information

Public title

A study related to the risk factors and their proliferation of head, neck and esophageal cancers

Acronym

The relation between HPV infection and head, neck and esophageal cancers

Scientific Title

A study related to the risk factors and their proliferation of head, neck and esophageal cancers

Scientific Title:Acronym

The relation between HPV infection and head, neck and esophageal cancers

Region

Japan


Condition

Condition

Head, neck and/or esophageal cancers

Classification by specialty

Gastroenterology Gastrointestinal surgery Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Clinicopathological characteristics of patients with head, neck and/or esophageal cancers related to the HPV infection

Basic objectives2

Others

Basic objectives -Others

HPV infection rate and its influence to the proliferation of cancers

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Differences in clinicopathological characteristics and prognosis between patients with head, neck and/or esophageal cancers with and without 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent surgery for head, neck cancer and/or esophageal cancer

Key exclusion criteria

Patients who did not agree this study protocol

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Noriaki
Middle name
Last name Manabe

Organization

Kawasaki Medical School

Division name

Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine

Zip code

700-8505

Address

2-6-1, Nakasange, Kita-ku, Okayama

TEL

086-225-2111

Email

n_manabe@med.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name Noriaki
Middle name
Last name Manabe

Organization

Kawasaki Medical School

Division name

Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine

Zip code

700-8505

Address

2-6-1, Nakasange, Kita-ku, Okayama

TEL

086-462-1111

Homepage URL


Email

n_manabe@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kawasaki Medical School

Address

577 Matsushima, Kurashiki, Okayama

Tel

086-462-1111

Email

kenkyu-idai1@med.kawasaki-m.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

2017 Year 12 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

No longer recruiting

Date of protocol fixation

2017 Year 08 Month 28 Day

Date of IRB

2017 Year 10 Month 16 Day

Anticipated trial start date

2017 Year 10 Month 16 Day

Last follow-up date

2021 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective case-control study


Management information

Registered date

2017 Year 09 Month 17 Day

Last modified on

2021 Year 09 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033350


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name