UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023309 |
|---|---|
| Receipt number | R000026859 |
| Scientific Title | Retrospective Investigation of CT and MRI Imaging Features of Tubulocystic Renal Cell Carcinoma. |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2019/07/27 09:29:17 |
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Basic information
Public title
Retrospective Investigation of CT and MRI Imaging Features of Tubulocystic Renal Cell Carcinoma.
Acronym
Retrospective Investigation of CT and MRI Imaging Features of Tubulocystic Renal Cell Carcinoma.
Scientific Title
Retrospective Investigation of CT and MRI Imaging Features of Tubulocystic Renal Cell Carcinoma.
Scientific Title:Acronym
Retrospective Investigation of CT and MRI Imaging Features of Tubulocystic Renal Cell Carcinoma.
Region
| Japan |
Condition
Condition
Tubulocystic Renal Cell Carcinoma(TC-RCC), Collecting Duct Carcinoma(CDC), Papillary Renal Cell Carcinoma(P-RCC), Multilocular Cystic Renal Cell Carcinoma(MC-RCC), Cystic Nephroma(CN), Mixed Epithelial and Stromal Tumor of Kidney(MEST)
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the CT and MR imaging features for Tubulocystic Renal Cell Carcinoma.
Basic objectives2
Others
Basic objectives -Others
The same as purpose 1.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Imaging features of Tubulocystic Renal Cell Carcinoma in comparison with Collecting Duct Carcinoma, Papillary Renal Cell Carcinoma, Multilocular Cystic Renal Cell Carcinoma, Cystic nephroma, and Mixed Epithelial and Stromal Tumor of Kidney. Descriptively summarize the following evaluation items on CT and MRI images among tumors; diameter, borderline, internal structure, necrosis, bleeding, invasion, calcification, venous tumor thrombus, dynamic pattern, CT index, Low intensity of T2, T2 STAR or SWI, observation of T1 in-opposed phase, observation of DWI,
pathological staging, Bosniak classfication
Key secondary outcomes
Not applicable.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients(Pts.) histopathologically diagnosed as TC-RCC, CDC, MC-RCC, CN, MEST from Jan 2005 to Mar 2016.
2. Pts. histopathologically diagnosed as P-RCC from Jan 2015 to Dec 2015.
3. Pts. Who were performed MDCT and / or MRI, followed resection within 6 months.
4. Pts. histopathologically definitive diagnosed.
5. Acceptable regardless of hospitalization, outpatient.
6. Acceptable regardless of gender.
Key exclusion criteria
1. Pts. before surgery for renal tumors receiving chemotherapy surgery within six months ago.
2. Pts. receiving chemotherapy for renal tumors after CT or MRI.
3. Double registration of the same patient is prohibited.
4. Any other pts. who are determined ineligible for this study by investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Awai |
Organization
Institute and Graduate School of Biomedical Sciences. Hiroshima University
Division name
Department of diagnostic radiology
Zip code
7340037
Address
Hiroshima
TEL
+81822575257
honday@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Honda |
Organization
Institute and Graduate School of Biomedical Sciences. Hiroshima University
Division name
Department of diagnostic radiology
Zip code
7340037
Address
Kasumi 1-2-3, minami-ku, Hiroshima, Japan
TEL
082-257-5257
Homepage URL
honday@hiroshima-u.ac.jp
Sponsor or person
Institute
Institute and Graduate School of Biomedical Sciences. Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center of integrated medical research. Hiroshima University
Address
1-2-3 Kasumi Minami-Ku
Tel
+81822575257
kasumi-kenkyu@office.hiroshima-u.ac.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
| 2016 | Year | 08 | 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
| 2016 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 10 | Month | 31 | Day |
Other
Other related information
Imaging features of Tubulocystic Renal Cell Carcinoma in comparison with Collecting Duct Carcinoma, Papillary Renal Cell Carcinoma, Multilocular Cystic Renal Cell Carcinoma, Cystic nephroma, and Mixed Epithelial & Stromal Tumor of Kidney. Descriptively summarize the following evaluation items on CT and MRI images among tumors; diameter, borderline, internal structure, necrosis, bleeding, invasion, calcification, venous tumor thrombus, dynamic pattern, CT index, Low intensity of T2, T2 STAR or SWI, observation of T1 in-opposed phase, observation of DWI,
pathological staging, Bosniak classfication
Management information
Registered date
| 2016 | Year | 07 | Month | 24 | Day |
Last modified on
| 2019 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026859
| 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 |
