UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042631 |
|---|---|
| Receipt number | R000048647 |
| Scientific Title | The impact of texture analysis in kidney stone |
| Date of disclosure of the study information | 2020/12/03 |
| Last modified on | 2022/12/05 20:33:51 |
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Basic information
Public title
The impact of texture analysis in kidney stone
Acronym
The impact of texture analysis in kidney stone
Scientific Title
The impact of texture analysis in kidney stone
Scientific Title:Acronym
The impact of texture analysis in kidney stone
Region
| Japan |
Condition
Condition
kidney stone
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently a texture analysis using CT or MRI image has become available ant its usefulness has been reported. In this study, we evaluated the efficacy of texture analysis in renal stone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The consistency of results of cluster analyses and stone compositions
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with kidney stone of more than 1.2ml in volume undergoing TUL or PNL in our institution from September 2014 to March 2020 are included.
Key exclusion criteria
Patients whose result of stone composition were not available are excluded.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kobayashi |
Organization
Tokyo Metropolitan Ohtsuka Hospital
Division name
Urology
Zip code
170-8476
Address
2-8-1 Minami-Ohtsuka, Toshima-ku, Tokyo, Japan
TEL
03-3941-3211
angel_sapporo_0329@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kobayashi |
Organization
Tokyo Metropolitan Ohtsuka Hospital
Division name
Urology
Zip code
170-8476
Address
2-8-1 Minami-Ohtsuka, Toshima-ku, Tokyo, Japan
TEL
03-3941-3211
Homepage URL
angel_sapporo_0329@yahoo.co.jp
Sponsor or person
Institute
Tokyo Metropolitan Ohtsuka Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Ohtsuka 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
Tokyo Metropolitan Ohtsuka Hospital
Address
2-8-1 Minami-Ohtsuka, Toshima-ku, Tokyo, Japan
Tel
03-3941-3211
angel_sapporo_0329@yahoo.co.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
| 2020 | Year | 12 | Month | 03 | 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
| 2020 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 04 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 04 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 04 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 04 | Day |
Other
Other related information
Nothing
Management information
Registered date
| 2020 | Year | 12 | Month | 02 | Day |
Last modified on
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048647
| 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 |
