UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter cooperative observational study of reactivation of hepatitis B virus caused by everolimus or sorafenib
Title of the study (Brief title)	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	Masafumi Ikeda, MD.
Organization	National Cancer Center Hospital East
Division name	Division of Hepatobiliary and Pancreatic Oncology
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	Masafumi Ikeda, MD.
Organization	National Cancer Center Hospital East
Division name	HBV surveillance data center
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 07 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000006371