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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005370
Receipt No. 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

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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
Email 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
Email masikeda@east.ncc.go.jp

Sponsor
Institute Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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