UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005369
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

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Basic information

Public title

Multicenter cooperative observational study of reactivation of hepatitis B virus caused by anticancer treatments for solid tumors

Acronym

HBV surveillance Solid tumor

Scientific Title

Multicenter cooperative observational study of reactivation of hepatitis B virus caused by anticancer treatments for solid tumors

Scientific Title:Acronym

HBV surveillance Solid tumor

Region

Japan


Condition

Condition

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.

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 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.

Basic objectives2

Others

Basic objectives -Others

Incidence rate of HBV reactivation
Outcome of the patients in whom the HBV reactivation developed

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Incidence rate of HBV reactivation
Outcome of the patients in whom the HBV reactivation developed

Key secondary outcomes

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


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 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

Key exclusion criteria

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

Target sample size

300


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



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 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

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

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

2010 Year 07 Month 09 Day

Date of IRB


Anticipated trial start date

2010 Year 08 Month 01 Day

Last follow-up date

2013 Year 05 Month 31 Day

Date of closure to data entry

2013 Year 07 Month 31 Day

Date trial data considered complete

2013 Year 07 Month 31 Day

Date analysis concluded

2013 Year 12 Month 31 Day


Other

Other related information

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.


Management information

Registered date

2011 Year 04 Month 02 Day

Last modified on

2013 Year 10 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006370


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name