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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040280
Receipt No. R000045957
Scientific Title Research to elucidate the anti-tumor immune responses and develop the combination therapy in solid tumor
Date of disclosure of the study information 2020/05/01
Last modified on 2020/05/01

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Basic information
Public title Research to elucidate the anti-tumor immune responses and develop the combination therapy in solid tumor
Acronym Research to elucidate the anti-tumor immune responses and develop the combination therapy in solid tumor
Scientific Title Research to elucidate the anti-tumor immune responses and develop the combination therapy in solid tumor
Scientific Title:Acronym Research to elucidate the anti-tumor immune responses and develop the combination therapy in solid tumor
Region
Japan

Condition
Condition Solid tumor
Classification by specialty
Medicine in general Surgery in general
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Profiling of state of tumor and immune responses at solid tumor from clinical patients.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analysis of tumor cells and immune cells in tumor microenvironment and peripheral blood.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who doubted solid tumor in clinically or confirmed solid tumor histologically.
2) Patients who plan to give biopsy or surgery.
3) Patients who gave informed consent by oneself.
Key exclusion criteria The cases an attending physician determined ineligible.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hideaki
Middle name
Last name Tahara
Organization Osaka International Cancer Institute, Research center
Division name Department of Cancer Drug Discovery and Development
Zip code 541-8567
Address 3-1-69, Otemae, Chuo-ku, Osaka-shi, Osaka
TEL 06-6945-1181
Email tahara@ims.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Yu
Middle name
Last name Mizote
Organization Osaka International Cancer Institute, Research center
Division name Department of Cancer Drug Discovery and Development
Zip code 541-8567
Address 3-1-69, Otemae, Chuo-ku, Osaka-shi, Osaka
TEL 06-6945-1181
Homepage URL
Email u-mizote@ims.u-tokyo.ac.jp

Sponsor
Institute Osaka International Cancer Institute, Research center
Institute
Department

Funding Source
Organization Ono Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka International Cancer Institute, Clinical research administration Control center
Address 3-1-69, Otemae, Chuo-ku, Osaka-shi, Osaka
Tel 06-6945-1181
Email rinri01@opho.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
2020 Year 05 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 26 Day
Date of IRB
2018 Year 10 Month 26 Day
Anticipated trial start date
2018 Year 10 Month 26 Day
Last follow-up date
2021 Year 10 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 05 Month 01 Day
Last modified on
2020 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045957

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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