Unique ID issued by UMIN | UMIN000005369 |
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Receipt number | R000006370 |
Scientific Title | Multicenter cooperative observational study of reactivation of hepatitis B virus caused by anticancer treatments for solid tumors |
Date of disclosure of the study information | 2011/04/10 |
Last modified on | 2013/10/03 01:10:25 |
Multicenter cooperative observational study of reactivation of hepatitis B virus caused by anticancer treatments for solid tumors
HBV surveillance Solid tumor
Multicenter cooperative observational study of reactivation of hepatitis B virus caused by anticancer treatments for solid tumors
HBV surveillance Solid tumor
Japan |
Solid tumor patients with seropositivity for HBsAg, or seronegativity for HBsAg and seropositivity for HBcAb and/or HBsAb, receiving first chemotherapy including neoadjuvant and adjuvant chemotherapy.
Medicine in general |
Malignancy
NO
To estimate the incidence rate of hepatitis B virus (HBV) reactivation for solid tumor patients with high risk of HBV reactivation receiving first chemotherapy, and investigate the outcome of the patients
in whom the HBV reactivation developed.
Others
Incidence rate of HBV reactivation
Outcome of the patients in whom the HBV reactivation developed
Exploratory
Not applicable
Incidence rate of HBV reactivation
Outcome of the patients in whom the HBV reactivation developed
Investigation of the background of patients in whom the HBV reactivation developed
Difference of outcome of the patients between obedience and non-obedience of Japanese guideline of HBV reactivation
Observational
Not applicable |
Not applicable |
Male and Female
1)Solid tumor patients receiving first chemotherapy including neoadjuvant and adjuvant chemotherapy.
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
1) During hemodialyis or planning to introuce hemodialyis.
2) Seropositivity to HCVAb
3) Seropositivity for HBsAb only with a history of HBV vaccination
4) Not eligible judged by investigators
300
1st name | |
Middle name | |
Last name | Masafumi Ikeda, MD. |
National Cancer Center Hospital East
Division of Hepatobiliary and Pancreatic Oncology
6-5-1 Kashiwanoha, Kashiwa Chiba, 277-8577, Japan
04-7133-1111
1st name | |
Middle name | |
Last name | Masafumi Ikeda, MD. |
National Cancer Center Hospital East
HBV surveillance data center
Division of Physiological examination, 6-5-1 Kashiwanoha, Kashiwa Chiba, 277-8577, Japan
04-7133-1111
masikeda@east.ncc.go.jp
Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East
Ministry of Health, Labour and Welfare
Japan
NO
2011 | Year | 04 | Month | 10 | Day |
Unpublished
Completed
2010 | Year | 07 | Month | 09 | Day |
2010 | Year | 08 | Month | 01 | Day |
2013 | Year | 05 | Month | 31 | Day |
2013 | Year | 07 | Month | 31 | Day |
2013 | Year | 07 | Month | 31 | Day |
2013 | Year | 12 | Month | 31 | Day |
Prospective cohort study
HBV DNA are measured periodically, 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.
2011 | Year | 04 | Month | 02 | Day |
2013 | Year | 10 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006370
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