UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038312 |
|---|---|
| Receipt number | 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 09:18:52 |
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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
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
komori.atsumasa.qr@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Nagasaki Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043355
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
