UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038109 |
|---|---|
| Receipt number | R000043433 |
| Scientific Title | Examination of impact on prognosis and recurrence Direct-Acting Antiviral for hepatitis C-related hepatocellular carcinoma after Treatment. |
| Date of disclosure of the study information | 2019/09/26 |
| Last modified on | 2021/03/28 10:57:24 |
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Basic information
Public title
Examination of Direct-Acting Antiviral treatment for hepatitis C on prognosis and recurrence of hepatocellular carcinoma
Acronym
Examination on prognosis and recurrence of DAA hepatocellular carcinoma
Scientific Title
Examination of impact on prognosis and recurrence Direct-Acting Antiviral for hepatitis C-related hepatocellular carcinoma after Treatment.
Scientific Title:Acronym
Examination of impact on prognosis and recurrence DAA for hepatitis C-related hepatocellular carcinoma after Treatment.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigate the prognosis and recurrence effect of DAA administration for hepatitis C after hepatocellular carcinoma treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prognosis after treatment for hepatocellular carcinoma
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Pathological or abdominal ultrasonography (including contrast imaging with sonazoid), contrast-enhanced CT, EOB-MRI, diagnosed as a liver malignant tumor.
2) Patients who have been confirmed that there is no hepatocellular carcinoma by contrast-enhanced CT or EOB-MRI within 3 months after surgery after hepatectomy or RFA as the first treatment.
3) A patient with Child-Pugh classification A before hepatectomy or RFA.
4) DAA of non-administration is the first case of HCC.
5) In case of DAA is administered, wether of HCC may be the first or recurrence.
Key exclusion criteria
1) Patients who have been refused participation in this study.
2) Child-Pugh before liver resection or RFA is B or C.
3) Cases with distant metastasis before HCC treatment.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ochi |
| Middle name | |
| Last name | Hironori |
Organization
Matsuyama Red Cross Hospital
Division name
Center for Liver-Billiary-Pancreas
Zip code
7908524
Address
Bunkyo-cho 1, Matsuyama, Ehime.
TEL
0899241111
hironori19810211@gmail.com
Public contact
Name of contact person
| 1st name | Ochi |
| Middle name | |
| Last name | Hironori |
Organization
Matsuyama Red Cross Hospital
Division name
Center for Liver-Billiary-Pancreas
Zip code
7908524
Address
Bunkyo-cho 1, Matsuyama, Ehime.
TEL
0899241111
Homepage URL
hironori19810211@gmail.com
Sponsor or person
Institute
Matsuyama Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsuyama Red Cross Hospital
Address
Center for Liver-Billiary-Pancreas
Tel
0899241111
hironori19810211@gmail.com
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
| 2019 | Year | 09 | Month | 26 | 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
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
A retrospective study to confirm the effect
Management information
Registered date
| 2019 | Year | 09 | Month | 26 | Day |
Last modified on
| 2021 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043433
| Research Plan | |
|---|---|
| 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 |
