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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011389
Receipt No. 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

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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
Email 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
Email sassa@med.nafoya-u.ac.jp

Sponsor
Institute Nagoya University, the department of Urology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013148

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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