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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038312
Receipt No. R000043355
Scientific Title Stereotactic body radiotherapy and radiofrequency ablation for early hepatocellular carcinoma-A prospective observational study
Date of disclosure of the study information 2019/10/16
Last modified on 2019/12/20

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Basic information
Public title Potential abscopal effect of stereotactic body radiotherapy on the recurrence of hepatocellular carcinoma: An exploratory observation study
Acronym Effect of stereotactic body radiotherapy on the recurrence
of hepatocellular carcinoma: An exploratory observation study
Scientific Title Stereotactic body radiotherapy and radiofrequency ablation for early hepatocellular carcinoma-A prospective observational study
Scientific Title:Acronym Stereotactic body radiotherapy and radiofrequency ablation for early hepatocellular carcinoma-A prospective observational study
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 By comparing the local and nonlocal recurrence rate after stereotactic body radiotherapy (SBRT) and radiofrequency abration to early hepatocellular carcionoma (HCC), and by analyzing the association between the post-treatment changes in immunostimulatory serum factors and HCC recurrence, the inhibitory effect of SBRT on HCC recurrence through potential abscopal effect is exploratory evaluated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Local and nonlocal Recurrence
Key secondary outcomes

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
20 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Solitary hepatocellular carcinoma (HCC) no larger than 30 mm in diameter without portal invasion or extrahepatic metastasis
(2)HCC diagnosed with early enhancement and late washout by contrast-enhanced computed tomography or by EOB-magnetic resonance imaging
(3) Primary, or recurred HCC being detected after longer than 6 months from initial treatament
Key exclusion criteria (1) Child-Pugh Score C
(2) Performance Status 3-4
(3) Pregnant or potentially pregnant female
Target sample size 280

Research contact person
Name of lead principal investigator
1st name Atsumasa
Middle name
Last name Komori
Organization National Hospital Organization Nagasaki Medical Center
Division name Clinical Research Center
Zip code 856-8562
Address Kubara 2-1001-1, Omura city, Japan
TEL 0957-52-3121
Email komori.atsumasa.qr@mail.hosp.go.jp

Public contact
Name of contact person
1st name Atsumasa
Middle name
Last name Komori
Organization National Hospital Organization Nagasaki Medical Center
Division name Clinical Research Center
Zip code 856-8562
Address Kubara 2-1001-1, Omura city, Japan
TEL 0957-52-3121
Homepage URL
Email komori.atsumasa.qr@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Nagasaki Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization funding for operating expenses
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 National Hospital Organization central institutional review board
Address Higashigaoka-2-5-21, Meguro ku, Tokyo
Tel 03-5712-5075
Email 700-kenkyu@mail.hosp.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 独立行政法人国立病院機構長崎医療センター(長崎県) 
独立行政法人国立病院機構仙台医療センター(宮城県) 
独立行政法人国立病院機構横浜医療センター(神奈川県)
独立行政法人国立病院機構まつもと医療センター(長野県) 
独立行政法人国立病院機構大阪医療センター(大阪府) 
独立行政法人国立病院機構呉医療センター(広島県) 
独立行政法人国立病院機構岡山医療センター(岡山県) 
独立行政法人国立病院機構小倉医療センター(福岡県)
独立行政法人国立病院機構名古屋医療センター(愛知県)
独立行政法人国立病院機構京都医療センター(京都府) 
独立行政法人国立病院機構大阪南医療センター(大阪府) 
独立行政法人国立病院機構嬉野医療センター(佐賀県) 
独立行政法人国立病院機構東京医療センター(東京県) 
独立行政法人国立病院機構熊本医療センター(熊本県) 
独立行政法人国立病院機構別府医療センター(大分県)
独立行政法人国立病院機構渋川医療センター(群馬県) 
独立行政法人国立病院機構旭川医療センター(北海道) 
独立行政法人国立病院機構高崎総合医療センター(群馬県) 
独立行政法人国立病院機構九州がんセンター(福岡県)
独立行政法人国立病院機構愛媛医療センター(愛媛県)
独立行政法人国立病院機構福山医療センター(広島県)

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 16 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
2019 Year 09 Month 13 Day
Date of IRB
2019 Year 09 Month 13 Day
Anticipated trial start date
2019 Year 10 Month 16 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2019 Year 10 Month 16 Day
Last modified on
2019 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043355

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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