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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038748
Receipt No. R000044175
Scientific Title Effect of immunotherapy on oncological and patientst reported outcomes in patients with metastatic renal cell cancer
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/30

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Basic information
Public title Effect of immunotherapy on oncological and patientst reported outcomes in patients with metastatic renal cell cancer
Acronym Effect of immunotherapy on oncological and patientst reported outcomes in patients with metastatic renal cell cancer
Scientific Title Effect of immunotherapy on oncological and patientst reported outcomes in patients with metastatic renal cell cancer
Scientific Title:Acronym Effect of immunotherapy on oncological and patientst reported outcomes in patients with metastatic renal cell cancer
Region
Japan

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

Objectives
Narrative objectives1 Investigate effects of immunotherapy on oncological and patient reported outcomes inpatients with metastatic renal cell cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effects of immunotherapy on oncological outcomes inpatients with renal cell cancer
Key secondary outcomes Effects of immunotherapy on patient reported outcomes inpatients with renal cell cancer

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment group: Patients received immunotherapy for metastatic renal cell cancer
Interventions/Control_2 Control group: Standard tyrosine kinase inhibitors for metastatic renal cell cancer
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
100 years-old >
Gender Male and Female
Key inclusion criteria Urothelial cancer who need systemic therapy or immunotherapy
Key exclusion criteria History of severe cardiac conditions, such as angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. History of drug, alcohol, or substance abuse within the 6 months before Visit 1.
Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to therapy and QoL
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Shingo
Middle name
Last name Hatakeyama
Organization Hirosaki Univ.
Division name Urology
Zip code 036-8562
Address 5 Zaifu-chou, Hirosaki, Japan
TEL +81172395091
Email shingoh@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name Shingo
Middle name Hatakeyama
Last name Hatakeyama
Organization Dept. of Urology, Hirosaki University Graduate School of Medicine
Division name Urology
Zip code 036-8562
Address Hirosaki
TEL +81172395091
Homepage URL
Email shingoh@hirosaki-u.ac.jp

Sponsor
Institute Dept. of Urology, Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization Dept. of Urology, Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hirosaki University Graduate School of Medicine
Address 5 Zaifu-chou, Hirosaki, Japan
Tel 0172-33-5111
Email rinri@hirosaki-u.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
2019 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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2024 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 30 Day
Last modified on
2019 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044175

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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