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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007601
Receipt No. 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

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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
Email 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
Email daichioka@yahoo.co.jp

Sponsor
Institute Department of Urology, Tsukuba University Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008979

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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