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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030670
Receipt No. R000035015
Scientific Title Regulatory T cells and M2 polarized tumor-associated macrophages are associated with oncogenesis and progression of oral squamous cell carcinoma
Date of disclosure of the study information 2018/01/09
Last modified on 2019/07/15

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Basic information
Public title Regulatory T cells and M2 polarized tumor-associated macrophages are associated with oncogenesis and progression of oral squamous cell carcinoma
Acronym Regulatory T cells and M2 polarized tumor-associated macrophages are associated with oncogenesis and progression of oral squamous cell carcinoma
Scientific Title Regulatory T cells and M2 polarized tumor-associated macrophages are associated with oncogenesis and progression of oral squamous cell carcinoma
Scientific Title:Acronym Regulatory T cells and M2 polarized tumor-associated macrophages are associated with oncogenesis and progression of oral squamous cell carcinoma
Region
Japan

Condition
Condition Oral Cancer
Classification by specialty
Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Regulatory T cells (Tregs) and tumor-associated macrophages (TAMs) contribute to the tumor microenvironment by inhibiting anti-tumor immune response. This study aimed to investigate the role of Tregs and TAMs in oral squamous cell carcinoma (OSCC) and oral epithelial precursor lesion (OEPL).
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In the present study, we examined the correlation between Treg and M2 TAM infiltration in OSCC and OEPL specimens based on the expression of M2 macrophage markers CD163 and CD204, and Treg markers CD25 and FoxP3 assessed by immunohistochemistry. Furthermore, we investigated the association between Treg and M2 TAM presence in tumors and clinicopathological characteristics of OSCC and OEPL patients.
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
30 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria OSCC or OEPL
Stage1-4
Male or female (30yo-90yo)
Key exclusion criteria Patients disagreing this test
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Mariko
Middle name
Last name Oikawa
Organization Tohoku University Graduate School of Dentistry
Division name Division of Oral Pathology, Department of Oral Medicine and Surgery,
Zip code 980-8575
Address 4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL 022-717-8303
Email kouketsu_atsumu@dent.tohoku.ac.jp

Public contact
Name of contact person
1st name Atsumu
Middle name
Last name Kouketsu
Organization Tohoku University Hospital
Division name Oral surgery
Zip code 980-8575
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL 022-717-8350
Homepage URL
Email kouketsu_atsumu@dent.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital Oral surgery
Institute
Department

Funding Source
Organization Tohoku University Hospital Oral surgery
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 Tohoku University Hospital Oral surgery
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
Tel 022-717-8350
Email kouketsu_atsumu@dent.tohoku.ac.jp

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
2018 Year 01 Month 09 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 Preinitiation
Date of protocol fixation
2018 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 05 Day
Last follow-up date
2021 Year 01 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 01 Month 04 Day
Last modified on
2019 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035015

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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