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 |
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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
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
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
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
