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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014480
Receipt No. 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

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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
Email 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
Email morikawa@z5.keio.jp

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

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016845

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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