UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025630 |
|---|---|
| Receipt number | R000029486 |
| Scientific Title | Identification of the association of cyst-infected bacteria and enterobacterial flora |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2023/01/16 14:43:19 |
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Basic information
Public title
Identification of the association of cyst-infected bacteria and enterobacterial flora
Acronym
Study to identify the mechanism of cyst infection
Scientific Title
Identification of the association of cyst-infected bacteria and enterobacterial flora
Scientific Title:Acronym
Study to identify the mechanism of cyst infection
Region
| Japan |
Condition
Condition
Polycystic kidney disease
Polycystic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Nephrology | Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To identify the mechanism of cyst infections to improve these patients' survival and quality of life
Basic objectives2
Others
Basic objectives -Others
To identify the mechanism of cyst-infection for seeking new treatment and its prevention
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Similarity of the characteristics between cyst-infected flora and enterobacterial flora
Key secondary outcomes
Infection-free survival
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
Patients who are diagnosed as having polycystic kidney or liver disease, and will receive cyst drainage.
Key exclusion criteria
Patients under age of 20
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Ubara |
Organization
Toranomon hospital
Division name
Nephrology Center
Zip code
1058470
Address
2-2-2, Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
hoshino@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Hoshino |
Organization
Toranomon hospital
Division name
Nephrology Center
Zip code
1058470
Address
2-2-2, Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
Homepage URL
hoshino@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Toranomon Hospital
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
Toranomon Hospital
Address
2-2-2, Toranomon, Minato-ku, Tokyo
Tel
0335881111
chiken-jim@toranomon.gr.jp
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
| 2017 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 11 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 11 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 11 | Day |
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 01 | Month | 11 | Day |
Last modified on
| 2023 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029486
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
