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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008405
Receipt No. R000009887
Scientific Title Association macrophages which express B7 family molecules and tumor infiltrating lymphocytes in colorectal liver metastases
Date of disclosure of the study information 2012/07/11
Last modified on 2014/01/23

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Basic information
Public title Association macrophages which express B7 family molecules and tumor infiltrating lymphocytes in colorectal liver metastases
Acronym Association macrophages which express B7 family molecules and tumor infiltrating lymphocytes in colorectal liver metastases
Scientific Title Association macrophages which express B7 family molecules and tumor infiltrating lymphocytes in colorectal liver metastases
Scientific Title:Acronym Association macrophages which express B7 family molecules and tumor infiltrating lymphocytes in colorectal liver metastases
Region
Japan

Condition
Condition colorectal liver metastases
Classification by specialty
Surgery in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate the number of tumor infiltrating lymphocytes (TIL) and tumor associated macrophages (TAM) in colorectal liver metastases. And we investigate association these number and clinicopathological factors or prognosis. Futhermore we evaluate the expression of B7 family molecules and investigate association its expression and several factors. The aim of this study is to reveal antitumor immune tolerance mechanism through these investigations.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Association the number of TIL or TAM and prognosis
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients who were diagnosed as having colorectal liver metastases and underwent liver resection
Key exclusion criteria nothing paticular
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tanaka Kuniya
Organization Yokohama City University,Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yokohama City University,Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Gastroenterological Surgery, Yokohama City University,Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterological Surgery Yokohama City University Graduate 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

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 11 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
2012 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is retrospective study that uses resected spicimens of colorectal liver metastases.

Management information
Registered date
2012 Year 07 Month 11 Day
Last modified on
2014 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009887

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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