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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039928
Receipt No. R000045506
Scientific Title Retrospective study to assess renal function using MAG3 renogram in patients with renal tumor who treated by carbon ion radiotherapy
Date of disclosure of the study information 2020/04/01
Last modified on 2020/03/25

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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 Open public recruiting
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
2020 Year 03 Month 25 Day


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

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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