UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039538 |
|---|---|
| Receipt number | R000045067 |
| Scientific Title | Assessment of quality of life using Japanese version of Bladder Cancer Index questionnaire in patients before and after radical cystectomy : a multicenter prospective observational study |
| Date of disclosure of the study information | 2020/02/19 |
| Last modified on | 2022/08/26 18:41:45 |
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Basic information
Public title
Assessment of quality of life using Japanese version of Bladder Cancer Index questionnaire in patients before and after radical cystectomy : a multicenter prospective observational study
Acronym
Assessment of quality of life using Japanese version of Bladder Cancer Index questionnaire in patients before and after radical cystectomy : a multicenter prospective observational study
Scientific Title
Assessment of quality of life using Japanese version of Bladder Cancer Index questionnaire in patients before and after radical cystectomy : a multicenter prospective observational study
Scientific Title:Acronym
Assessment of quality of life using Japanese version of Bladder Cancer Index questionnaire in patients before and after radical cystectomy : a multicenter prospective observational study
Region
| Japan |
Condition
Condition
Bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate QOL before and after radical cystectomy using disease-specific patient-reported outcome measure, Bladder Cancer Index and also differences in QOL between urinary diversion.
Basic objectives2
Others
Basic objectives -Others
To evaluate minimally important difference of Bladder Cnacer Index
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in quality of life before and after radical cystectomy
Key secondary outcomes
To evaluate minimally important difference of Bladder Cnacer Index
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
Male or female patients 20 years of age or older on the day of consent
Patients who will undergo open, laparoscopic or robot assisted radical cystectomy
Voluntary written consent must be given after sufficient explanation with the understanding what this study is and that consent may be withdrawn by the patient at any time without prejudice to future medical care
Key exclusion criteria
The patients who have distant metastasis
The patients being treated for cancer other than bladder cancer
The patients taking antipsychotics, antidepressants and anxiolytics
The patients who are regarded as inappropriate for entering this study by principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Shinohara |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Renal and Genitourinary surgery
Zip code
060-8638
Address
North15 West7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-5966
nozomis@mbj.nifty.com
Public contact
Name of contact person
| 1st name | Shuhei |
| Middle name | |
| Last name | Yamada |
Organization
Hokkaido University Hospital
Division name
Department of Renal and Genitourinary surgery
Zip code
060-8638
Address
North14 West5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-716-1161
Homepage URL
yshu1229@gmail.com
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Urological association young research grant
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
multi-center study
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital
Address
North14 West5, Kita-ku, Sapporo, Hokkaido, Japan
Tel
011-716-1161
yshu1229@gmail.com
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
北海道がんセンター（北海道）、自治医大学付属病院（栃木県）、筑波大学付属病院（茨城県）、弘前大学病院（青森県）、慈恵医大柏病院（千葉県）、大阪大学病院（大阪府）、札幌医科大学病院（北海道）、帯広厚生病院（北海道）、横浜市立大学附属市民総合医療センター（神奈川県）、東京慈恵会医科大学（東京都）、山梨大学病院（山梨県）、函館五稜郭病院（北海道）、熊本大学病院（熊本県）、山口大学病院（山口県）、国立がん研究センター東病院（千葉県）、九州大学病院（福岡市）、香川大学病院（香川県）宮崎大学病院（宮崎県）、原三信病院（福岡県）、愛知県がんセンター（愛知県）、久留米大学病院（福岡県）、鹿児島大学病院（鹿児島県）、四国がんセンター（愛媛県）、市立釧路総合病院（北海道）、北海道大学病院（北海道）、京都大学病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 02 | Month | 19 | Day |
Last modified on
| 2022 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045067
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/09/15 | [No.019-0043]計画書 2.0版【200129承認】 - IADL追加.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
