UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005370 |
|---|---|
| Receipt number | R000006371 |
| Scientific Title | Multicenter cooperative observational study of reactivation of hepatitis B virus caused by everolimus or sorafenib |
| Date of disclosure of the study information | 2011/04/10 |
| Last modified on | 2017/04/06 23:20:21 |
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Basic information
Public title
Multicenter cooperative observational study of reactivation of hepatitis B virus caused by everolimus or sorafenib
Acronym
HBV surveillance study RADSOR
Scientific Title
Multicenter cooperative observational study of reactivation of hepatitis B virus caused by everolimus or sorafenib
Scientific Title:Acronym
HBV surveillance study RADSOR
Region
| Japan |
Condition
Condition
Maligant tumor patients with high risk of hepatitis B viral reactivation receiving chemotherapy in which everolimus or sorafenib is contained.
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the incidence rate of hepatitis B virus (HBV) reactivation for maligant tumor patients with high risk of HBV reactivation receiving chemotherapy in which everolimus or sorafenib is contained, and investigate the outcome of the patients in whom the HBV reactivation developed
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence rate of HBV reactivation
Key secondary outcomes
Outcome of the patients in whom the HBV reactivation developed
Investigation of the background of patients in whom the HBV reactivation developed
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
1)Solid tumor patients receiving chemotherapy in which everolimus and sorafenib is contained
2)Patients with high risk of HBV reactivation:
1.Seropositivity for HBsAg
2.Seronegativity for HBsAg and seropositivity for HBcAb and/or HBsAb
3)Written informed consent
Key exclusion criteria
1) No prior treatment of everolimus and sorafenib
2) During hemodialyis or planning to introuce hemodialyis.
3) Seropositivity to HCVAb
4) Seropositivity for HBsAb only with a history of HBV vaccination
5) Not eligible judged by investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Ikeda, MD. |
Organization
National Cancer Center Hospital East
Division name
Division of Hepatobiliary and Pancreatic Oncology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa Chiba, 277-8577, Japan
TEL
04-7133-1111
masikeda@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Ikeda, MD. |
Organization
National Cancer Center Hospital East
Division name
HBV surveillance data center
Zip code
Address
Division of Physiological examination, 6-5-1 Kashiwanoha, Kashiwa Chiba, 277-8577, Japan
TEL
04-7133-1111
Homepage URL
masikeda@east.ncc.go.jp
Sponsor or person
Institute
Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Terminated
Date of protocol fixation
| 2010 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Prospective cohort study
HBV DNA are measured monthly, and investigate the incidence of HBV reactivation.
In the patient in whom the HBV reactivation developed, serum HBV related marker including HBsAg, HBV core-related antigen, HBcAb, HBsAb, sequence and mutation analysis of HBV genes.
Management information
Registered date
| 2011 | Year | 04 | Month | 02 | Day |
Last modified on
| 2017 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006371
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
