UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025086 |
|---|---|
| Receipt number | R000028849 |
| Scientific Title | Predictive and prognostic biomarkers of immune checkpoint inhibitors in renal cell, urothelial, and other urological carcinomas |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2024/06/06 15:08:34 |
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Basic information
Public title
Predictive and prognostic biomarkers of immune checkpoint inhibitors in renal cell, urothelial, and other urological carcinomas
Acronym
BINIR study
Scientific Title
Predictive and prognostic biomarkers of immune checkpoint inhibitors in renal cell, urothelial, and other urological carcinomas
Scientific Title:Acronym
BINIR study
Region
| Japan |
Condition
Condition
Renal cell cercinoma
urothelial carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore novel predictive and prognostic biomarkers of immune checkpoint inhibitors treatment for renal cell and urothelial carcinoma
Basic objectives2
Others
Basic objectives -Others
Explore for novel biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of progression-free survival (PFS) according to serumchemoline levels and T cell receptor (TCR) repertoire
Key secondary outcomes
The relationship between survivals and , regulatory T cells, MDSC, or other chemokines
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 with unresectable or metastatic renal cell carcinoma who will be treated with immune checkpoint inhibitorsr and patients with unresectable or metastatic urothelial carcinoma who will be treated with immune checkpoint inhibitorsr will be recruited.
Key exclusion criteria
Patients who are pregnant or have past history of allergy to immune checkpoint inhibitorsr will be excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kouji |
| Middle name | |
| Last name | Izumi |
Organization
Kanazawa University
Division name
Department of Integrative Cancer Therapy and Urology
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL
076-265-2393
azuizu2003@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kouji |
| Middle name | |
| Last name | Izumi |
Organization
Kanazawa University
Division name
Department of Integrative Cancer Therapy and Urology
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL
076-265-2393
Homepage URL
azuizu2003@yahoo.co.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee of Kanazawa University
Address
13-1 Takaramachi, Kanazawa, Japan
Tel
0762652834
rinri@adm.kanazawa-u.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
| 2016 | Year | 12 | 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
| 2016 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Serum CCL2 and other ckemokines, whole blood TCR repertoire, the number of blood Treg and MDSC are measured before nivolumab and pembrolizumab treatment (0 week) and at 3 (pembrolizumab) or 4 (nivolumab) weeks after commencement of treatment. The relationship between survival data including progression-free and overall survival and serum CCL2, other ckemokines, whole blood TCR repertoire, or the number of blood Treg and MDSC will be analyzed.
Management information
Registered date
| 2016 | Year | 11 | Month | 30 | Day |
Last modified on
| 2024 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028849
