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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029172
Receipt No. 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 2018/04/28

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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
Middle name
Last name Noriaki Manabe
Organization Kawasaki Medical School
Division name Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code
Address 577 Matsushima, Kurashiki, Japan
TEL 086-462-1111
Email n_manabe@hkg.odn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriaki Manabe
Organization Kawasaki Medical School
Division name Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code
Address 577 Matsushima, Kurashiki, Japan
TEL 086-462-1111
Homepage URL
Email n_manabe@hkg.odn.ne.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
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
2018 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.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


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