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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032901
Receipt No. R000037514
Scientific Title The investigation of safety and efficacy of short hydration GC therapy in metastatic urothelial carcinoma patients
Date of disclosure of the study information 2018/06/20
Last modified on 2018/06/07

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Basic information
Public title The investigation of safety and efficacy of short hydration GC therapy in metastatic urothelial carcinoma patients
Acronym The investigation of safety and efficacy of short hydration GC therapy
Scientific Title The investigation of safety and efficacy of short hydration GC therapy in metastatic urothelial carcinoma patients
Scientific Title:Acronym The investigation of safety and efficacy of short hydration GC therapy
Region
Japan

Condition
Condition advanced or metastatic urothelial carcinoma patients
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To estimate the efficacy and safety of short hydration GC therapy using QOL questionnare and wearable device.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes adverse events
Key secondary outcomes physiological items
CBC
blood examination
serum CRP level
renal function ex, eGFR
response rate
secondary adverse events
QOL estimation
activity estimated by Fitbits

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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. urothelial carcinoma patients diagnosed by histology
2. Stage3-4, Stage2 ly+ v+ bladder cancer patients and T4 or N+, M+ upper urinary tract cancer patients.
3. patients aged 20-80 yrs
4. life expectancy is more than 3 mos
5. ECOG-PS 0-2 patients.
6. WBC > 4000, neutrophil > 2000, Hb >9, Platlet > 100000, T-bilirubin < 1.5, AST < 66, ALT < 54, creatinine < 1.7 in male, < 1.1 in female.
Key exclusion criteria 1. patients who had allergy in gemcitabine
2. patients who had allergy in cisplatin
3. previously treated patients by gemcitabine, or cisplatin
4. patients who had sign of interstitial pneumoniae or pulmonary fibrosis
5. patients previously treated in chest by radiation therapy
6. patients who have infection or fever
7. pregnant patients
8. patients giving lactation
9. patients including severe diseases
10. unadequate patients
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taku Naiki
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Nephro-urology
Zip code
Address kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan
TEL 052-853-8266
Email naiki@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taku Naiki
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Nephro-urology
Zip code
Address kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan
TEL 052-853-8266
Homepage URL http://www.med.nagoya-cu.ac.jp/uro.dir/
Email naiki@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 20 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
2018 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 10 Day
Last follow-up date
2020 Year 04 Month 15 Day
Date of closure to data entry
2020 Year 04 Month 15 Day
Date trial data considered complete
2022 Year 04 Month 15 Day
Date analysis concluded
2022 Year 04 Month 15 Day

Other
Other related information none

Management information
Registered date
2018 Year 06 Month 07 Day
Last modified on
2018 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037514

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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