UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective study to assess renal function using MAG3 renogram in patients with renal tumor who treated by carbon ion radiotherapy
Acronym	Retrospective study to assess renal function using MAG3 renogram in patients with renal tumor who treated by carbon ion radiotherapy
Scientific Title	Retrospective study to assess renal function using MAG3 renogram in patients with renal tumor who treated by carbon ion radiotherapy
Scientific Title:Acronym	Retrospective study to assess renal function using MAG3 renogram in patients with renal tumor who treated by carbon ion radiotherapy
Region	Japan

Condition
Condition	Renal tumor
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the method using MAG3 renogram before and after carbon ion radiotherapy in patients with renal tumor 1. Evaluation of split renal function 2. Treatment response and prognosis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of diagnostic abilities of MAG3 renogram in terms of prediction of renal function before and after(up to 7 years) carbon ion radiotherapy
Key secondary outcomes	Correlation among renal function predicted by MAG3 renogram and renal function index by prognosis, imaging

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	Patients underwent MAG3 renogram, among who were treated with carbon ion radiotherapy for renal tumors from January 2014 to March 2020 at QST hospital.
Key exclusion criteria	1.Other cause of death within 12 months after carbon ion radiotherapy. 2.Patients who were received other anticancer treatments within 4 months after carbon ion radiotherapy. 3.Patients who refuse to participate in this study.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kana Middle name Last name Yamazaki
Organization	National Institute of Radiological Sciences (NIRS), QST
Division name	Dept. of Molecular Imaging and Theranostics
Zip code	263-8555
Address	4-9-1 Anagawa, Inage-ku, Chiba
TEL	043-206-4076
Email	yamazaki.kana@qst.go.jp

Public contact
Name of contact person	1st name Kana Middle name Last name Yamazaki
Organization	National Institute of Radiological Sciences (NIRS), QST
Division name	Dept. of Molecular Imaging and Theranostics
Zip code	263-8555
Address	4-9-1 Anagawa, Inage-ku, Chiba
TEL	043-206-4076
Homepage URL
Email	yamazaki.kana@qst.go.jp

Sponsor
Institute	National Institute of Radiological Sciences (NIRS), QST
Institute
Department

Funding Source
Organization	None
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	Certified Review Board, QST
Address	4-9-1 Anagawa, Inage-ku
Tel	043-206-4706
Email	helsinki@qst.go.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 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	2020 Year 03 Month 18 Day
Date of IRB	2020 Year 03 Month 18 Day
Anticipated trial start date	2020 Year 03 Month 20 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2020 Year 03 Month 25 Day
Last modified on	2022 Year 09 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045506