UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016678 |
|---|---|
| Receipt number | R000019355 |
| Scientific Title | Analysis of tumor immune microenvironments and host immune responses in cancer patients |
| Date of disclosure of the study information | 2015/03/02 |
| Last modified on | 2021/04/06 21:31:23 |
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Basic information
Public title
Analysis of tumor immune microenvironments and host immune responses in cancer patients
Acronym
Analysis of tumor immune microenvironments and host immune responses
Scientific Title
Analysis of tumor immune microenvironments and host immune responses in cancer patients
Scientific Title:Acronym
Analysis of tumor immune microenvironments and host immune responses
Region
| Japan |
Condition
Condition
malignancy
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
analysis of tumor immune microenvironment and host immune responses against cancer antigen in cancer patients
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Investigation of methods and biomarker for the prognosis of malignacy using immune factors
Key secondary outcomes
1)prospective
analysis of tumor immune microenvironmens and host immune responses
: os,pfs,rr
2)investigation of methods and biomarker for the prognosis of malignacy using immune factors: os,pfs,rr
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.ECOG performance status 0-2
2.Under the hematological toxicity of Grade3
Key exclusion criteria
Sever complications
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Mikio |
| Middle name | |
| Last name | Oka |
Organization
Kawasaki Medical School
Division name
Department of Immuno-Oncology
Zip code
701-0192
Address
577 Matsusima, Kurashiki
TEL
086-462-1111
resp@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Kurose |
Organization
Kawasaki Medical School
Division name
Respiratory Medicine
Zip code
701-0192
Address
577 Matsusima, Kurashiki
TEL
086-462-1111
Homepage URL
kuro-ko.66@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Kawasaki Medical School
Address
577 Matsushima, Kurashiki, Okayama
Tel
086-462-1111
kmsrec@med.kawasaki-m.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
| 2015 | Year | 03 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
prospective
analysis of tumor immune microenvironmens and host immune responses
: os,pfs,rr
investigation of methods and biomarker for the prognosis of malignacy using immune factors: os,pfs,rr
Management information
Registered date
| 2015 | Year | 03 | Month | 02 | Day |
Last modified on
| 2021 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019355
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
