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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000004378 |
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Date of registration:
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21/10/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A single immediate postoperative prophylactic intravesical instillation of Pirarubicin following transurethral resection of non-muscle invasive bladder cancer
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Scientific title:
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A single immediate postoperative prophylactic intravesical instillation of Pirarubicin following transurethral resection of non-muscle invasive bladder cancer - A single immediate postoperative prophylactic intravesical instillation of Pirarubicin for non-muscle invasive bladder cancer |
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Date of first enrolment:
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2010/11/01 |
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Target sample size:
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80 |
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Recruitment status: |
Pending |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005234 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase I,II
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hideaki Miyake |
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Address:
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7-5-1, Kusunoki-cho, Kobe
Japan |
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Telephone:
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078-382-6155 |
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Email:
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hideakimiyake@hotmail.com |
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Affiliation:
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Kobe University Graduate School of Medicine Division of Urology |
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Name:
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Masato Fujisawa |
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Address:
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7-5-1, Kusunoki-cho, Kobe
Japan |
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Telephone:
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078-382-6155 |
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Email:
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uro6155@med.kobe-u.ac.jp |
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Affiliation:
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Kobe University Graduate School of Medicine Division of Urology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: (1) patients with duplex of active other malignant disease. (2) Patients with history or present disease of upper urinary tract utotherial carcinoma. (3) Patients with severe disfunction of renal, liver, hematopoietic or heart. (4) Patients with history of allergic reaction against doxorubicin or epirubicin
Age minimum:
Not applicable
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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non-muscle invasive bladder cancer (pTa and low grade)
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Intervention(s)
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Immediate intravesical instillation of Pirarubicin 30 mg following transurethral resection of bladder cancer
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Primary Outcome(s)
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Duration of recurrence-free survival
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Secondary Outcome(s)
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Two-year recurrence free survival rate Safty
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Source(s) of Monetary Support
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none
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/10/2014 |
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URL:
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