UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030670
Receipt number 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 2021/04/20 09:52:38

* 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

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 or person

Institute

Tohoku University Hospital Oral surgery

Institute

Department

Personal name



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

Completed

Date of protocol fixation

2018 Year 01 Month 05 Day

Date of IRB

2018 Year 01 Month 05 Day

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

2021 Year 04 Month 20 Day

Date trial data considered complete

2021 Year 04 Month 20 Day

Date analysis concluded

2021 Year 04 Month 20 Day


Other

Other related information

None


Management information

Registered date

2018 Year 01 Month 04 Day

Last modified on

2021 Year 04 Month 20 Day



Link to view the page

Value
https://center6.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