UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007601 |
|---|---|
| Receipt number | R000008979 |
| Scientific Title | Multiinstitutional study on evaluation methods of renal function before and during chemotherapy for urothelial cancer |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2018/05/30 14:53:08 |
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Basic information
Public title
Multiinstitutional study on evaluation methods of renal function before and during chemotherapy for urothelial cancer
Acronym
CURE study
Scientific Title
Multiinstitutional study on evaluation methods of renal function before and during chemotherapy for urothelial cancer
Scientific Title:Acronym
CURE study
Region
| Japan |
Condition
Condition
Unresectable or metastatic urothelial carcinoma treated with systemic chemotherapy
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this retrospective study, using medical records of urothelial cancer patients, the various evaluation methods of renal function and cut off level for decision making will be extensively reviewed. This study is conducted to test the effect of each evaluation method and cut off level on protocol modification, treatment response, adverse events and survival outcome of patients treated with systemic chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of dose modification in the 1st-line chemotherapy.
Key secondary outcomes
1. The rate of regimen modification in the 1st-line chemotherapy.
2. Response rate in the 1st-line chemotherapy.
3. Overall survival rate.
4. Cancer-specific survival rate
5. Frequency of adverse effects.
6. Response rate in the 2nd-line chemotherapy.
7. Response rate in the 3rd-line chemotherapy.
8. Correlation among the measured results in renal function by different methods.
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
1. Patients with histologically diagnosed urothelial carcinoma (*).
2. Patients with unresectable or metastatic urothelial carcinoma.
3. Patients treated with the 1st-line systemic chemotherapy from January 1, 2004 to December 31, 2010.
4. Aged 20 or older.
*) Include ureteropelvic cancer which clinically diagnosed as urothelial carcinoma by cytologic and imaging diagnosis.
Key exclusion criteria
1. Patients given the first systemic chemotherapy before December 31, 2003.
2. Patients with active cancers in other organs at the start of systemic chemotherapy.
Target sample size
370
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Nishiyama |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Urology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3196
nishiuro@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daishi Ichioka |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Urology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3223
Homepage URL
daichioka@yahoo.co.jp
Sponsor or person
Institute
Department of Urology, Tsukuba University Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tsukuba Clinical Research & Development Organization
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
| 2012 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/jjco/article-lookup/doi/10.1093/jjco/hyv082
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
Main results already published
Date of protocol fixation
| 2012 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | 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
Retrospective cohort study
Management information
Registered date
| 2012 | Year | 03 | Month | 29 | Day |
Last modified on
| 2018 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008979
