UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008405 |
|---|---|
| Receipt number | 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 22:52:03 |
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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
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
Sponsor or person
Institute
Department of Gastroenterological Surgery, Yokohama City University,Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009887
