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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028814
Receipt No. 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 2019/08/26

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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
Email 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
Email nozawa06@med.kindai.ac.jp

Sponsor
Institute Department of Urology, Kindai University Faculty of Medicine
Institute
Department

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
Email 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
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 Open public recruiting
Date of protocol fixation
2017 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 25 Day
Last follow-up date
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
2019 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032977

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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