UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015939
Receipt number R000018548
Scientific Title The significance of FOXC2 expresion in the oral tongue squamous cell carcinoma atients.
Date of disclosure of the study information 2014/12/25
Last modified on 2014/12/14 10:43:39

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Basic information

Public title

The significance of FOXC2 expresion in the oral tongue squamous cell carcinoma atients.

Acronym

The significance of FOXC2 expresion in the oral tongue squamous cell carcinoma atients.

Scientific Title

The significance of FOXC2 expresion in the oral tongue squamous cell carcinoma atients.

Scientific Title:Acronym

The significance of FOXC2 expresion in the oral tongue squamous cell carcinoma atients.

Region

Japan


Condition

Condition

oral tongue squamous cell carcinoma

Classification by specialty

Oral surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The examination of FOXC2 expression in oral tongue squamous cell carcinoma.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The immunohistochemical staining of oral tongue squamous cell carcinoma biopsy specimans with anti-FXC2 and anti- VEGF antibody. The association with the expression of these molecules and clinicopathological features is examined.

Key secondary outcomes

To examine wheatherThe expression of FOXC2 may be a prognostic factor in oral tongue squamous cell carcinoma patients.


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Orak tongue squamous cell carcinomaatients with the hisotopathological diagnosis.

2. Patients with no NAC.

Key exclusion criteria

1.Petints with NAC.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naomi Imayama

Organization

Nagasaki University

Division name

Department of Clinical Oral Oncology

Zip code


Address

Sakamoto1-7-1, Nagasaki, Japan

TEL

095-819-7698

Email

n-imayama@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shin-ichi Yamada

Organization

Nagasaki University

Division name

Deprtment of Clinical Oral Oncology

Zip code


Address

Sakamoto 1-7-1, Japan

TEL

095-819-7698

Homepage URL


Email

shinshin@nagasaki-u.ac.jp


Sponsor or person

Institute

Department of Clinical Oral Oncology, Nagasaki Univesity

Institute

Department

Personal name



Funding Source

Organization

Nagasaki University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japna


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

長崎大学病院


Other administrative information

Date of disclosure of the study information

2014 Year 12 Month 25 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

Preinitiation

Date of protocol fixation

2014 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 01 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry

2015 Year 03 Month 31 Day

Date trial data considered complete

2015 Year 03 Month 31 Day

Date analysis concluded

2015 Year 03 Month 31 Day


Other

Other related information

The immunohistochemical eaxaminetion of ora tongue squamous cell carcinoma biopsy specimans is performed with anti-FOXC2 antibody and anti-VEGF antibody.
The pattern of these molecules in the tumor tissue and examine the asociation with clinicopathological features.


Management information

Registered date

2014 Year 12 Month 14 Day

Last modified on

2014 Year 12 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018548


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name