UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021854 |
|---|---|
| Receipt number | R000025199 |
| Scientific Title | Study the role of water channels in human bladder epithelium involved in water re-absorption function |
| Date of disclosure of the study information | 2016/04/10 |
| Last modified on | 2017/10/11 10:20:09 |
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Basic information
Public title
Study the role of water channels in human bladder epithelium involved in water re-absorption function
Acronym
Study the role of water channels in human bladder epithelium
Scientific Title
Study the role of water channels in human bladder epithelium involved in water re-absorption function
Scientific Title:Acronym
Study the role of water channels in human bladder epithelium
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
It is pointed out that human bladder may be involved in resorption of moisture in the bladder, but its detailed mechanism is unknown.
As a candidate for water channel responsible for water reabsorption in the human bladder, aquaporin (water channel present in cell membrane, water enters and exits intracellularly and extracellularly) and gap junction (water channel of intercellular junction, water Confirmed its existence and structure at the histological and electron microscopic level and confirmed the possibility that human bladder is involved in reabsorption of intravesical water retention moisture .
In addition, sodium ion channel, chloride ion channel and water channel function in human bladder are verified by short-circuit current measurement and functionally confirm water reabsorption in human bladder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At our hospital we perform total bladder cystectomy for bladder cancer, and from the specimen we pick up, we can gather parts that are considered macroscopically normal tissue. In the collected tissues, the presence and the structure of aquaporin 3 and aquaporin 1, whose presence is predicted in human bladder tissue, existence and structure are confirmed at the collaborative research institution at the histological and electron microscopic level . Especially, normal bladder tissues immediately after removal are loaded into the Ussing chamber and the functions and control mechanisms of the sodium ion channel / chloride ion channel / water channel are clarified. Furthermore, in order to confirm whether the tissue used in this study is a normal tissue, some specimens for tissue diagnosis are also stored at the time of tissue collection.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
At our hospital we perform total bladder cystectomy for bladder cancer, and from the specimen we pick up, we can gather parts that are considered macroscopically normal tissue. In the collected tissues, the presence and the structure of aquaporin 3 and aquaporin 1, whose presence is predicted in human bladder tissue, existence and structure are confirmed at the collaborative research institution at the histological and electron microscopic level . Especially, normal bladder tissues immediately after removal are loaded into the Ussing chamber and the functions and control mechanisms of the sodium ion channel / chloride ion channel / water channel are clarified. Furthermore, in order to confirm whether the tissue used in this study is a normal tissue, some specimens for tissue diagnosis are also stored at the time of tissue collection.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent cystectomy against bladder cancer in our hospital
Key exclusion criteria
Not applicable
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ukimura Osamu |
Organization
Kyoto Prefectural University of Medicine
Division name
Urology
Zip code
Address
465 kaji-cho,Kamigyo-ku Kyoto,Japan,602-8566
TEL
075-251-5595
ukimura@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Nomura |
Organization
Kyoto Prefectural University of Medicine
Division name
Urology
Zip code
Address
465 kaji-cho,Kamigyo-ku Kyoto,Japan,602-8566
TEL
075-251-5595
Homepage URL
takeshi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
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
| 2016 | Year | 04 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | 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
Management information
Registered date
| 2016 | Year | 04 | Month | 10 | Day |
Last modified on
| 2017 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025199
