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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003163
Receipt No. 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

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

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
URL(English) https://upload.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


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