UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014480 |
|---|---|
| Receipt number | R000016845 |
| Scientific Title | Elucidation of the surrounding stromal cells malignant transformation mechanism parallel to oral cancer development |
| Date of disclosure of the study information | 2014/07/04 |
| Last modified on | 2017/09/27 18:21:04 |
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Basic information
Public title
Elucidation of the surrounding stromal cells malignant transformation mechanism parallel to oral cancer development
Acronym
Elucidation of the surrounding stromal cells malignant transformation mechanism parallel to oral cancer development
Scientific Title
Elucidation of the surrounding stromal cells malignant transformation mechanism parallel to oral cancer development
Scientific Title:Acronym
Elucidation of the surrounding stromal cells malignant transformation mechanism parallel to oral cancer development
Region
| Japan |
Condition
Condition
Oral cancer
Classification by specialty
| Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Lead to therapeutic strategies to locate cancer formation promoting factor in each stromal cell fraction (angiogenic factor, lymphangiogenesis factor, inflammation-related mediators), focused on the stromal cells in the digestive cancer and other oral cancer.
Basic objectives2
Others
Basic objectives -Others
1.Were separated by flow cytometer indicator cell surface antigen, the mesenchymal cells in the pathogenesis cancer lesions, carcinoma in situ, invasive carcinoma prior to analyzing the properties
2.To verify the cancer formation promoting factor each pathology, in each mesenchymal cell fraction
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.The context of the (Grade) the degree of epithelial dysplasia in oral precancerous lesions.
2.Invasion depth of oral cancer, associated histopathological therapeutic effect histological grade (degree of differentiation), style invasion, vascular invasion, and neural invasion, and (only chemotherapy example).
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
Visited the School of Medicine, Keio University Hospital, Dental and Oral Surgery in five years, Keio University School of Medicine Ethics Committee approval after diagnosis (leukoplakia, erythroplakia, lichen planus), and oral cancer oral precancerous lesions clinically is, adult patients who have undergone surgery or biopsy.
Key exclusion criteria
1.Patients having a double cancer
2.Patients with a history of chemotherapy in the past
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Morikawa |
Organization
Keio University School of Medicine
Division name
Department of Dentistry and Oral Surgery,
Zip code
Address
Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
morikawa@z5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Morikawa |
Organization
Keio University School of Medicine
Division name
Department of Dentistry and Oral Surgery,
Zip code
Address
Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
morikawa@z5.keio.jp
Sponsor or person
Institute
Department of Dentistry and Oral Surgery, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Dentistry and Oral Surgery, Keio University School of Medicine
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 04 | 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
| 2011 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
nested case-control study
Management information
Registered date
| 2014 | Year | 07 | Month | 04 | Day |
Last modified on
| 2017 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016845
