UMIN-CTR Clinical Trial

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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