UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020709 |
|---|---|
| Receipt number | R000023896 |
| Scientific Title | Comprehensive search of SNPs in patients with advanced renal cell carcinoma associated with efficacy and adverse events of molecular targeted therapies |
| Date of disclosure of the study information | 2016/01/25 |
| Last modified on | 2016/01/23 14:31:19 |
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Basic information
Public title
Comprehensive search of SNPs in patients with advanced renal cell carcinoma associated with efficacy and adverse events of molecular targeted therapies
Acronym
Search of SNPs associated with efficacy and adverse event of molecular targeted therapies for renal cell carcinoma
Scientific Title
Comprehensive search of SNPs in patients with advanced renal cell carcinoma associated with efficacy and adverse events of molecular targeted therapies
Scientific Title:Acronym
Search of SNPs associated with efficacy and adverse event of molecular targeted therapies for renal cell carcinoma
Region
| Japan |
Condition
Condition
renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Identify the SNPs in patients with advanced renal cell carcinoma associated with efficacy and adverse events of molecular targeted therapies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identify the SNPs in patients with advanced renal cell carcinoma associated with efficacy and adverse events of molecular targeted therapies
Key secondary outcomes
1. Identify the clinical factors in patients with advanced renal cell carcinoma associated with efficacy and adverse events of molecular targeted therapies
2. Identify the SNPs associated with oncogenesis of renal cell carcinoma
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
blood sampling (5cc)
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
1. Renal cell carcinoma confirmed pathologically
2. Patients Treated or planed to be treated by molecular targeted therapy
3. Patients without severe complication in heart, lung, liver, kidney or other organ
4. Expected survival for 12 weeks or longer
5. Written informed consent
Key exclusion criteria
1. HIV infection, or B/C active hepatitis
2. Active infection (grade 3 or more defined by CTCAE version 3)
3. Inadequate case in physicians opinion
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Nakaigawa |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
3-9 Fukuura, Kanazawaku Yokohama 236-0004, Japan
TEL
045-787-2679
nakaigan@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noboru Nakaigawa |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
3-9 Fukuura, Kanazawaku Yokohama 236-0004, Japan
TEL
045-787-2679
Homepage URL
nakaigan@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Bayer in Japan, Pfizer Japan Inc., Novartis Pharma
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Yokohama City University
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
| 2016 | Year | 01 | Month | 25 | 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
| 2015 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 25 | 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
| 2016 | Year | 01 | Month | 23 | Day |
Last modified on
| 2016 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023896
