UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003163
Receipt number R000003610
Scientific Title New classification of oral squamous cell carcinoma based on the molecular expression profile controlling the epithelial mesenchymal transition and stem cell-like characteristics
Date of disclosure of the study information 2010/02/10
Last modified on 2010/02/10 13:39:24

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Basic information

Public title

New classification of oral squamous cell carcinoma based on the molecular expression profile controlling the epithelial mesenchymal transition and stem cell-like characteristics

Acronym

Molecular expression profile controlling the epithelial mesenchymal transition and stem cell-like characteristics in oral squamous cell carcinoma

Scientific Title

New classification of oral squamous cell carcinoma based on the molecular expression profile controlling the epithelial mesenchymal transition and stem cell-like characteristics

Scientific Title:Acronym

Molecular expression profile controlling the epithelial mesenchymal transition and stem cell-like characteristics in oral squamous cell carcinoma

Region

Japan


Condition

Condition

oral squamous cell carcinoma

Classification by specialty

Oral surgery Dental medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Epithelial mesenchymal transition (EMT) and stem cell-like characteristics are important phenomena for predicting the degree of malignancy and treatment resistance of oral squamous cell carcinoma. We propose to investigate the expression of the candidate genes that control these two phenomena in oral squamous cell carcinoma and its precancerous lesions. The purpose of this study is to determine the characteristic expression pattern of the selected genes related to tumor recurrence, metastasis and dysplastic change.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1)Relation to prognosis of oral squamous cell carcinoma
2)Relation to epithelial dysplasia in precancerous lesions

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

1)Pathologically confirmed oral squamous cell carcinoma
2)A tumor specimen is available
3)Age =>20 year

Key exclusion criteria

1)Patients with double cancer
2)Patients with previous chemotherapy against any other malignancies

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Seiji Asoda

Organization

School of Medicine, Keio University

Division name

Department of Dentistry and Oral Surgery

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

School of Medicine, Keio University

Division name

Department of Dentistry and Oral Surgery

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Dentistry and Oral Surgery, School of Medicine, Keio University

Institute

Department

Personal name



Funding Source

Organization

Department of Dentistry and Oral Surgery, School of Medicine, Keio University

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

2010 Year 02 Month 10 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

Enrolling by invitation

Date of protocol fixation

2009 Year 04 Month 10 Day

Date of IRB


Anticipated trial start date

2009 Year 09 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

nested case-control study


Management information

Registered date

2010 Year 02 Month 10 Day

Last modified on

2010 Year 02 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003610


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name