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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043415
Receipt No. R000049555
Scientific Title Clinical study investigating background factors that affect the prognosis of patients with relapsed or metastatic renal cell carcinoma
Date of disclosure of the study information 2021/02/23
Last modified on 2021/02/22

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Basic information
Public title Clinical study investigating background factors that affect the prognosis of patients with relapsed or metastatic renal cell carcinoma
Acronym Clinical study investigating background factors that affect the prognosis of patients with relapsed or metastatic renal cell carcinoma (JEWEL study)
Scientific Title Clinical study investigating background factors that affect the prognosis of patients with relapsed or metastatic renal cell carcinoma
Scientific Title:Acronym Clinical study investigating background factors that affect the prognosis of patients with relapsed or metastatic renal cell carcinoma (JEWEL study)
Region
Japan

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

Objectives
Narrative objectives1 To investigate background factors that affect the prognosis of patients with relapsed or metastatic renal cell carcinoma.
Basic objectives2 Others
Basic objectives -Others To investigate background factors that affect the prognosis of patients with relapsed or metastatic renal cell carcinoma.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes OS defined as the time from initiation of first-line treatment to death.
Key secondary outcomes Duration of first-line treatment.
OS by factor of interest.
Duration of first-line treatment by factor of interest.
Reasons for discontinuing first-line and second-line treatment by age.

Base
Study type Others,meta-analysis etc

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 Database provided by ARCHERY study
Refer from ARCHERY study (UMIN000034131) inclusion criteria.
Key exclusion criteria Not applicable
Refer from ARCHERY study (UMIN000034131) exclusion criteria.
Target sample size 770

Research contact person
Name of lead principal investigator
1st name Kaori
Middle name
Last name Ouchi
Organization Chugai Pharmaceutical Co., Ltd.
Division name Medical Affairs Div.
Zip code 103-8324
Address 1-1 Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo 103-8324, JAPAN
TEL 03-3273-0866
Email cma-clinicaltrial@chugai-pharm.co.jp

Public contact
Name of contact person
1st name Tomoko
Middle name
Last name Kotani
Organization SRL Medisearch Inc.
Division name Clinical Research Development
Zip code 163-0408
Address Shinjuku mitsui Building 8F 2 -1-1, Nishishinjuku, Shinjuku-ku, Tokyo 163-0408, JAPAN
TEL 050-2000-5231
Homepage URL
Email tomoko.kotani@hugp.com

Sponsor
Institute Chugai Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Kindai University
Health Data Deep Learning Team, Medical Sciences Innovation Hub Program, RIKEN
Name of secondary funder(s)

IRB Contact (For public release)
Organization MINS
Address 5-20-9-401, Mita, Minato-ku, Tokyo 108-0073, JAPAN
Tel 03-6416-1868
Email npo-mins@j-irb.com

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
2021 Year 02 Month 23 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
2021 Year 02 Month 08 Day
Date of IRB
2021 Year 01 Month 17 Day
Anticipated trial start date
2021 Year 08 Month 01 Day
Last follow-up date
2021 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Condition: renal cell carcinoma
Methods: Using the data from the ARCHERY study (UMIN000034131), we comprehensively investigate the relationship between the background factors of mRCC and prognosis. New data will not be acquired. Statistical analysis using this dataset is only performed.

Management information
Registered date
2021 Year 02 Month 22 Day
Last modified on
2021 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049555

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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