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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
