UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030400 |
|---|---|
| Receipt number | R000034714 |
| Scientific Title | Multiinstitutional prospective interventional study of biomarkers to predict efficacy and prognosis after nivolumab in patients with previously treated advanced renal cell carcinoma. |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/05/28 08:37:23 |
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Basic information
Public title
Multiinstitutional prospective interventional study of biomarkers to predict efficacy and prognosis after nivolumab in patients with previously treated advanced renal cell carcinoma.
Acronym
Multiinstitutional prospective interventional study of biomarkers to predict efficacy and prognosis after nivolumab in patients with previously treated advanced renal cell carcinoma.
Scientific Title
Multiinstitutional prospective interventional study of biomarkers to predict efficacy and prognosis after nivolumab in patients with previously treated advanced renal cell carcinoma.
Scientific Title:Acronym
Multiinstitutional prospective interventional study of biomarkers to predict efficacy and prognosis after nivolumab in patients with previously treated advanced renal cell carcinoma.
Region
| Japan |
Condition
Condition
Advanced renal cell carcinoma patients who need secondary or tertiary therapy
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Exploratory research for biomarkers related to the therapeutic effect of nivolumab for advanced renal cell carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Best Overall Response
Key secondary outcomes
OS,PFS,DSS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Nivolumab
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Advanced renal cell carcinoma with unresectable or metastatic history who had been treated with tyrosine kinase inhibitors, Over 20 years old patients confirmed CT/MRI, Neutrophils > 1500cells/mm2, platelets > 75000cells/mm2, hemoglobin >9.0g/dl, AST < 78IU/l, ALT < 85IU/l, total bilirubin < 1.5mg/dl, serum creatinine > 2.0mg/dl, written informed consent
Key exclusion criteria
Patients who have been administered immune checkpoint inhibitors including nivolumab in the past
Patients who have a history of malignant tumors other than renal cell carcinoma and are judged not to be cured
Patients who are merging psychiatric symptoms or psychiatric disorders and considered difficult to participate in the study
Patients decided not applicable for this study by physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Fujisawa |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Urology, Department of Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku Kobe
TEL
078-382-6155
uro6155@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Miyake |
Organization
Hamamatsu University School of Medicine
Division name
Department of Urology
Zip code
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2306
Homepage URL
hmiyake@hama-med.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical & Bristol-Myers Squibb
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 04 | Month | 01 | 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
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 14 | Day |
Last modified on
| 2018 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034714
| 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 |
