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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033039
Receipt No. 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

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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
Email 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
Email uro1801@cres-kyushu.or.jp

Sponsor
Institute Kindai University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037673

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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