UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028814 |
|---|---|
| Receipt number | R000032977 |
| Scientific Title | A prospective observational study on systemic treatment for advanced renal cell carcinoma |
| Date of disclosure of the study information | 2017/08/25 |
| Last modified on | 2022/08/29 16:57:03 |
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Basic information
Public title
A prospective observational study on systemic treatment for advanced renal cell carcinoma
Acronym
Advanced RCC Registry
Scientific Title
A prospective observational study on systemic treatment for advanced renal cell carcinoma
Scientific Title:Acronym
Advanced RCC Registry
Region
| Japan |
Condition
Condition
Advanced renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the association between treatment result and patient characteristics in real-world clinic
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment duration for every systemic treatment
Key secondary outcomes
Objective response
Time to response
Time to progression
Overall survival
Adverse event profile
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
Patients on treatment with systemic therapy with targeted agents
Key exclusion criteria
Patients on treatment with systemic therapy with targeted agents as pre-surgical treatment prior to cytoreductive nephrectomy.
Patients with cytokine therapy only.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Uemura |
Organization
Kindai University Faculty of Medicine
Division name
Urology
Zip code
5898511
Address
377-2, Ohno-higashi, Osaka-sayama
TEL
072-366-0221
nozawa06@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Nozawa |
Organization
Kindai University Faculty of Medicine
Division name
Urology
Zip code
5898511
Address
377-2, Ohno-higashi, Osaka-sayama
TEL
072-366-0221
Homepage URL
nozawa06@med.kindai.ac.jp
Sponsor or person
Institute
Department of Urology, Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co. Ltd., Bristol-Meyers Squibb K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Urology Research Foundation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University Faculty of Medicine
Address
377-2, Ohno-higashi, Osaka-sayama, Osaka
Tel
072-366-0221
nozawa06@med.kindai.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
| 2017 | Year | 08 | Month | 25 | 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
329
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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Treatment duration
Objective response
Time to response
Time to progression
Overall survival
Adverse event profile
Management information
Registered date
| 2017 | Year | 08 | Month | 24 | Day |
Last modified on
| 2022 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032977
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
