UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019340
Receipt number R000022353
Scientific Title Analysis of genes expression in Head and Neck Carcinoma: retrospective study
Date of disclosure of the study information 2015/10/15
Last modified on 2015/10/14 17:40:43

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Basic information

Public title

Analysis of genes expression in Head and Neck Carcinoma: retrospective study

Acronym

Gene analysis in Head and Neck Carcinoma

Scientific Title

Analysis of genes expression in Head and Neck Carcinoma: retrospective study

Scientific Title:Acronym

Gene analysis in Head and Neck Carcinoma

Region

Japan


Condition

Condition

Head and Neck Carcinoma

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To identify the specific genes associated with carcinogenesis of Head and Neck carcinoma

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The expression level of oncogenes and tumor suppressor genes in Head and Neck carcinoma

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

Head and Neck Carcinoma patients treated at Department of Otolaryngology-Head and Neck Surgery, Jichi Medical University, Department of Otolaryngology/Head and Neck Surgery, Hamamatsu University School of Medicine and Department of Head and Neck, Cancer Institute Hospital of Japanese Foundation for Cancer Research

Key exclusion criteria

patients less than 20-year-old

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeharu Kanazawa

Organization

Jichi Medical University

Division name

Department of Otolaryngology/Head and neck Surgery

Zip code


Address

3311-1 Yakushiji, Shimotsuke, Tochigi, Japan

TEL

0285-44-2111

Email

kanatake@omiya.jichi.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeharu Kanazawa

Organization

Jichi Medical University

Division name

Department of Otolaryngology/Head and neck Surgery

Zip code


Address

3311-1 Yakushiji, Shimotsuke, Tochigi, Japan

TEL

0285-44-2111

Homepage URL


Email

kanatake@omiya.jichi.ac.jp


Sponsor or person

Institute

Department of Otolaryngology/Head and neck Surgery, Jichi Medical University

Institute

Department

Personal name



Funding Source

Organization

Department of Otolaryngology/Head and neck Surgery, Jichi Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Head and Neck, Cancer Institute Hospital of Japanese Foundation for Cancer Research
Department of Otolaryngology/Head and Neck Surgery, Hamamatsu University School of Medicine

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

2015 Year 10 Month 15 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

Terminated

Date of protocol fixation

2015 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 05 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

multi-institutional retrospective observational study


Management information

Registered date

2015 Year 10 Month 14 Day

Last modified on

2015 Year 10 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022353


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name