UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Elucidation of the surrounding stromal cells malignant transformation mechanism parallel to oral cancer development
Title of the study (Brief title)	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	Satoru Morikawa
Organization	Keio University School of Medicine
Division name	Department of Dentistry and Oral Surgery,
Address	Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Email	morikawa@z5.keio.jp

Public contact
Name of contact person	Satoru Morikawa
Organization	Keio University School of Medicine
Division name	Department of Dentistry and Oral Surgery,
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 09 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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