UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038748 |
|---|---|
| Receipt number | 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 | 2023/03/21 10:19:25 |
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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
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
shingoh@hirosaki-u.ac.jp
Sponsor or person
Institute
Dept. of Urology, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
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
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
23
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
Terminated
Date of protocol fixation
| 2019 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2023 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044175
