UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000026859