UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006145 |
|---|---|
| Receipt number | R000007264 |
| Scientific Title | Urinary bladder cancer antigen test in the diagnosis of recurrence after radical nephroureterectomy in patients with upper urinary tract urothelial carcinoma |
| Date of disclosure of the study information | 2011/08/10 |
| Last modified on | 2016/02/10 09:06:49 |
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Basic information
Public title
Urinary bladder cancer antigen test in the diagnosis of recurrence after radical nephroureterectomy in patients with upper urinary tract urothelial carcinoma
Acronym
UBC test as a marker for upper urinary tract urothelial carcinoma
Scientific Title
Urinary bladder cancer antigen test in the diagnosis of recurrence after radical nephroureterectomy in patients with upper urinary tract urothelial carcinoma
Scientific Title:Acronym
UBC test as a marker for upper urinary tract urothelial carcinoma
Region
| Japan |
Condition
Condition
upper urinary tract urothelial carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine an efficacy of UBC ( Urinary Bladder Cancer antigens) as a urinary marker for detection of recurrence in the urinary tract
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of urinary recurrence
Key secondary outcomes
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
Patients who are diagnosed as upper urinary tract urothelial cancer and undergo radical nephroureterectomy
Key exclusion criteria
1) History of bladder cancer or concomitant bladder cancer
2) Pathological diagnosis other than urothelial carcinoma
3) Residual tumor after radical nephroureterectomy
4) Patients who undergo systemic chemotherapy after radical nephroureterectomy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihro Maeda |
Organization
Sapporo Medical University Hospital
Division name
Department of Urology
Zip code
Address
South 1 West 16, Chuo-ku, Sapporo 060-8543, Japan
TEL
011-611-2111
maeda-t@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Maeda |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Urology
Zip code
Address
South 1 West 16, Chuo-ku, Sapporo 060-8543, Japan
TEL
011-611-2111
Homepage URL
maeda-t@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
YAMASA CO., LTD
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
| 2011 | Year | 08 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | 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
Urinary UBC (CK8 and CK18) is compared with urinary cytology and urinary NMP22.
Urine samples are collected every 3 months until 3 years after radical nephroureterectomy.
Management information
Registered date
| 2011 | Year | 08 | Month | 10 | Day |
Last modified on
| 2016 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007264
