UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033039 |
|---|---|
| Receipt number | R000037673 |
| Scientific Title | Multicenter, prospective study using the novel predictive factor of the anti PD-1 antibody for urological cancers (renal cell carcinoma, urothelial cancer) |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2018/08/22 07:55:01 |
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Basic information
Public title
Multicenter, prospective study using the novel predictive factor of the anti PD-1 antibody for urological cancers (renal cell carcinoma, urothelial cancer)
Acronym
Prospective study using the novel predictive factor of the anti PD-1 antibody for urological cancers
Scientific Title
Multicenter, prospective study using the novel predictive factor of the anti PD-1 antibody for urological cancers (renal cell carcinoma, urothelial cancer)
Scientific Title:Acronym
Prospective study using the novel predictive factor of the anti PD-1 antibody for urological cancers
Region
| Japan |
Condition
Condition
renal cell carcinoma
urothelial cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Using novel peripheral blood biomarker, make clear that an effective patient of nivolumab or pembrolizumab of local progressive or metastatic renal cell carcinoma and urinary cancer is predictable
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between disease control rate and PBMC biomarker
Key secondary outcomes
ORR Objective Response Rate
TTF Time to Treatment Failure
PFS Progression Free Survival
OS Overall Survival
safety and tolerability
Comparison of the DCR, ORR PFS OS with non effective patient
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
renal cell carcinoma
1) Impossible of resection or metastatic clear cell RCC
2) The patient that the treatment with VEGFR tyrosine kinase repressor is enforced as previous treatment more than 1 course
3) Patient older than age at agreement acquisition 20 years old
4) The case that they receive enough explanation about this study contents, and a written agreement of person or alternate is provided
Urothelial cancer
1) Urinary cancer which is impossible of resection after the chemotherapy
2) The patient that treatment with platinum combination chemotherapy is enforced as previous treatment more than 1 course
3) Patient older than age at agreement acquisition 20 years old
4) The case that they receive enough explanation about this study contents, and a written agreement of person or alternate is provided
Key exclusion criteria
1)A synchronism overlap cancer or the patient whom a disease-free period has heterochrony overlap cancer within five years
*But I do not do Carcinoma in situ (cancer in the epithelium) and the intramucosal carcinoma judged that I was cured by local treatment with the exclusion.
2) The patient whom I am complicated with mental disease or a mind symptom, and it is judged to have difficulty in participation in study
3) The patient who gives it from head to foot of steroids more than four weeks
*But I permit it to the steroid within 10 mg/day by prednisolone conversion.
4) in addition, the patient that a study responsibility doctor or an allotment doctor judged the participation in this study to be inappropriate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Uemura |
Organization
Kindai University Faculty of Medicine
Division name
Department of Urology
Zip code
Address
377-2 Ohno-higashi, Osaka Sayama-shi, Osaka 589-8511 Japan
TEL
072-366-0221
huemura@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Toyoda |
Organization
Clinical Research Support Center Kyusyu
Division name
Data center
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582 Japan
TEL
092-631-2920
Homepage URL
uro1801@cres-kyushu.or.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
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 | 07 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | 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
To meet the endpoints, following items should be collected in this study:
-PBMC biomarker status in each time points
-Information of adverse events, treatment staus, disease progression, and survival
Management information
Registered date
| 2018 | Year | 06 | Month | 18 | Day |
Last modified on
| 2018 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037673
