UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011389 |
|---|---|
| Receipt number | R000013148 |
| Scientific Title | The evaluation of diagnostic techniques for upper urothelial carcinoma using the FISH method -Early diagnosis of postoperative intravesical recurrence with upper urothelial cancer-Evaluation of the genetic identity between bladder recurrence and upper urinary tract- |
| Date of disclosure of the study information | 2013/08/10 |
| Last modified on | 2014/02/07 08:40:05 |
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Basic information
Public title
The evaluation of diagnostic techniques for upper urothelial carcinoma using the FISH method
-Early diagnosis of postoperative intravesical recurrence with upper urothelial cancer-Evaluation of the genetic identity between bladder recurrence and upper urinary tract-
Acronym
The evaluation of diagnostic techniques for upper urothelial carcinoma using the FISH method
Scientific Title
The evaluation of diagnostic techniques for upper urothelial carcinoma using the FISH method
-Early diagnosis of postoperative intravesical recurrence with upper urothelial cancer-Evaluation of the genetic identity between bladder recurrence and upper urinary tract-
Scientific Title:Acronym
The evaluation of diagnostic techniques for upper urothelial carcinoma using the FISH method
Region
| Japan |
Condition
Condition
upper urinary urothelial carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To predict bladder recurrence using FISH and cytology after nephroureterectomy
Basic objectives2
Others
Basic objectives -Others
To evaluation the genetically identical between bladder tumor recurrence and upper urinary tract cancer
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
intravesical recurennce free survival
Key secondary outcomes
genetically identical
sensitivity using FISH and cytology
specificity using FISH and cytology
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with upper urinary tract tumors obviouslly
Nephroureteretmy will be performed. (Does not matter operative procedure, is not limited lymph node dissection)
The patients with no treatment before surgery (Chemotherapy, BCG therapy must not be done)
No past history with bladder cancer and consmitant bladder tumor (allowed those more than 5 years)t
Organ function to withstand the surgery, that the PS is good.
Key exclusion criteria
Patients with a history of bladder cancer
Patients with a history of treatment chemotherapy
PS is poor patient
Patients who did not obtain the consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Sassa |
Organization
Nagoya University
Division name
Urology
Zip code
Address
Showa-ku Tsurumai-Cho 65, Nagoya , Aichi
TEL
052-744-2985
sassa@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Sassa |
Organization
Nagoya University
Division name
Urology
Zip code
Address
Showa-ku Tsurumai-Cho 65, Nagoya, Aichi, Japan
TEL
052-744-2985
Homepage URL
sassa@med.nafoya-u.ac.jp
Sponsor or person
Institute
Nagoya University, the department of Urology
Institute
Department
Personal name
Funding Source
Organization
Nagoya University, the department of Urology
Organization
Division
Category of Funding 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
名古屋大学（愛知県）、名古屋第一赤十字病院（愛知県）、名古屋第二赤十字病院（愛知県）、国立名古屋医療センター（愛知県）、小牧市民病院（愛知県）、岡崎市民病院（愛知県）、中部労災病院（愛知県）、社会保険中京病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2013 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Genetic identity between bladder recurrence and upper urinary tract cancer, early predictive for bladder recurrece, prospective study,
Target cases were all cases for sampling
Management information
Registered date
| 2013 | Year | 08 | Month | 06 | Day |
Last modified on
| 2014 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013148
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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