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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029326
Receipt No. R000033521
Scientific Title The search for biomarkers reflecting tumor immune microenvironment for renal cell carcinoma
Date of disclosure of the study information 2017/12/01
Last modified on 2019/04/01

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Basic information
Public title The search for biomarkers reflecting tumor immune microenvironment for renal cell carcinoma
Acronym The search for biomarkers reflecting tumor immune microenvironment for renal cell carcinoma
Scientific Title The search for biomarkers reflecting tumor immune microenvironment for renal cell carcinoma
Scientific Title:Acronym The search for biomarkers reflecting tumor immune microenvironment for renal cell carcinoma
Region
Japan

Condition
Condition Renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The search for biomarkers for renal cell carcinoma by comparing between tumor immune microenvironment, immune environment in peripheral blood, and clinical data.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Survival
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients with renal cell carcinoma who underwent surgery in Tokyo Medical and Dental University between 2007 and 2016.
2.Patients with renal cell carcinoma who undergo surgery and/or drug therapy in Tokyo Medical and Dental University
Key exclusion criteria 1.Patients with human immunodeficiency virus or acquired immunodeficiency syndrome and related disorders
2.Patients with hepatitis B surface antigen
3.Patients with hepatitis C virus antibody
4.Patients undergoing steroid therapy
5.Patients during pregnancy and lactation
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Saito
Organization Tokyo Medical and Dental University, Medical Hospital
Division name Urology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo,Japan
TEL 03-3813-6111
Email kz-saito.uro@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutaka Saito
Organization Tokyo Medical and Dental University, Medical Hospital
Division name Urology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo,Japan
TEL 03-3813-6111
Homepage URL
Email kz-saito.uro@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University, Medical Hospital
Institute
Department

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
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
2017 Year 12 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
2017 Year 09 Month 28 Day
Date of IRB
2017 Year 11 Month 30 Day
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Research for immune environment for patients with renal cell carcinoma

Management information
Registered date
2017 Year 09 Month 28 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033521

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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