UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043415 |
|---|---|
| Receipt number | 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 | 2023/07/19 18:23:05 |
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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 | Kazuhiko |
| Middle name | |
| Last name | Nishi |
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
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
tomoko.kotani@hugp.com
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
Institute
Department
Personal name
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
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
北海道大学病院（北海道）、札幌医科大学附属病院（北海道）、弘前大学医学部附属病院（青森県）、岩手医科大学附属病院（岩手県）、筑波大学附属病院（茨城県）、東邦大学医療センター佐倉病院（千葉県）、慶應義塾大学病院（東京都）、東京医科歯科大学医学部附属病院（東京都）、日本医科大学付属病院（東京都）、北里大学病院（神奈川県）、横浜市立大学附属病院（神奈川県）、新潟大学医歯学総合病院（新潟県）、富山大学附属病院（富山県）、静岡県立静岡がんセンター（静岡県）、浜松医科大学医学部附属病院（静岡県）、愛知医科大学病院 （愛知県）、名古屋大学医学部附属病院（愛知県）、京都大学医学部附属病院（京都府）、大阪市立大学医学部附属病院（大阪府）、大阪大学医学部附属病院（大阪府）、近畿大学病院（大阪府）、神戸大学医学部附属病院（兵庫県）、奈良県立医科大学附属病院（奈良県）、岡山大学病院（岡山県）、徳島大学病院（徳島県）、香川大学医学部附属病院（香川県）、九州大学病院（福岡県）、長崎大学病院（長崎県）、熊本大学病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 23 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049555
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/iju.15244
Number of participants that the trial has enrolled
770
Results
A comprehensive analysis of baseline characteristics related to OS after initiation of first-line TKI therapy in patients with advanced metastatic RCC was executed. This analysis suggested that gender, age, ECOGPS, presence of liver or bone metastases, CRP, WHO/ISUP grade, LDH, and albumin were factors associated with prognosis.
Results date posted
| 2023 | Year | 07 | Month | 19 | Day |
Results Delayed
Results Delay Reason
None
Date of the first journal publication of results
| 2023 | Year | 07 | Month | 11 | Day |
Baseline Characteristics
The median age of TKI-treated patients was 66 years, and 434 patients (76%) were male. Most patients (n = 528; 93%) had clear-cell RCC and 41% of patients (n = 234) were PD-L1-positive. RCC with sarcomatoid features was observed in 64 patients (11%).
Participant flow
None
Adverse events
None
Outcome measures
None
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
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
| 2023 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049555
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| Registered date | File name |
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| Registered date | File name |
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