UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003558 |
|---|---|
| Receipt number | R000004317 |
| Scientific Title | Measurement of mRNA of predictive factors to chemotherapy in patients with superficial bladder cancer |
| Date of disclosure of the study information | 2010/05/06 |
| Last modified on | 2015/05/06 18:15:29 |
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Basic information
Public title
Measurement of mRNA of predictive factors to chemotherapy in patients with superficial bladder cancer
Acronym
Measurement of predictive factors to chemotherapy in patients with superficial bladder cancer
Scientific Title
Measurement of mRNA of predictive factors to chemotherapy in patients with superficial bladder cancer
Scientific Title:Acronym
Measurement of predictive factors to chemotherapy in patients with superficial bladder cancer
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
According to previous studies, the efficacy of UFT was reported in patients with superficical bladder cancer.
Recently, it was reported that the values of TS, DPD and OPRT were associated with effect of UFT in other cancers. However, there was no report about it in bladder cancer.
Therefore, it would be clinically of great benefit to evaluate the utility of TS, DPD and OPRT in bladder cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the association between the values of TS, DPD and OPRT and 1)pathological staging (TNM classification), 2)grade, 3)recurrence, 4)progression 5) metastasis 6) death
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
| 30 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with superficial bladder cancer who underwent trans urethral resection of bladder tumor at Keio University Hospital between 1992 and 2007.
Key exclusion criteria
The patients who have active other cancers, or received the treatment of bladder cancer at other hospital, or cannot come to hospital after operation regularly.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Kikuchi |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Urology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Keio University School of Medicine and Taiho Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Other
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
| 2010 | Year | 05 | Month | 06 | 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
In patients with 28 T1G3 bladder cancer, Elevated DPD mRNA level was significantly associated with recurrence (p=0.048) and progression (p=0.045). However, TS and OPRT mRNA levels were not significantly associated with any other clinical features or outcomes.
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
Completed
Date of protocol fixation
| 2010 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | 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
Cross-sectional study about association between the values of three enzymes and pathological staging and grade, or case control study about association between the values of three enzymes and prognosis.
Management information
Registered date
| 2010 | Year | 05 | Month | 01 | Day |
Last modified on
| 2015 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004317
