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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023309
Receipt No. 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

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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
Email 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
Email honday@hiroshima-u.ac.jp

Sponsor
Institute Institute and Graduate School of Biomedical Sciences. Hiroshima University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026859

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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