UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001299 |
|---|---|
| Receipt number | R000001562 |
| Scientific Title | A multicenter, observational study for reactivation of hepatitis B virus by means of serial HBV-DNA monitoring during and just after systemic chemotherapy containing rituximab plus steroid for malignant lymphoma (C-SHOT 0802) |
| Date of disclosure of the study information | 2008/08/11 |
| Last modified on | 2019/01/24 14:45:17 |
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Basic information
Public title
A multicenter, observational study for reactivation of hepatitis B virus by means of serial HBV-DNA monitoring during and just after systemic chemotherapy containing rituximab plus steroid for malignant lymphoma (C-SHOT 0802)
Acronym
HBV reactivation study during systemic chemotherapy containing rituximab plus steroid for malignant lymphoma (C-SHOT 0802)
Scientific Title
A multicenter, observational study for reactivation of hepatitis B virus by means of serial HBV-DNA monitoring during and just after systemic chemotherapy containing rituximab plus steroid for malignant lymphoma (C-SHOT 0802)
Scientific Title:Acronym
HBV reactivation study during systemic chemotherapy containing rituximab plus steroid for malignant lymphoma (C-SHOT 0802)
Region
| Japan |
Condition
Condition
Untreated CD20-positive, B-cell non-Hodgkin's lymphoma in the patients with seronegativity for HBsAg and seropositivity for HBc-Ab and/or HBs-Ab, which is planned to be treated with 6-8 courses of systemic chemotherapy containing rituximab plus steroid such as R-CHOP, R-CVP, R-THP-COP and R-C-MOPP
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the incidence of hepatitis B virus reactivation by means of serial HBV-DNA monitoring during and just after systemic chemotherapy containing rituximab plus steroid for the lymphoma patients with seronegativity for HBsAg and seropositivity for HBc-Ab and/or HBs-Ab, and to collect and analyse the data for establishing preemptive therapy using anti-HBV nucleoside analogue
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of hepatitis B virus (HBV) reactivation by means of serial HBV-DNA monitoring
Key secondary outcomes
Incidence of hepatitis due to HBV reactivation
Incidence of fulminant hepatitis due to HBV reactivation
Mortality caused by hepatitis due to HBV reactivation
Incidence of HBV reactivation following salvage chemotherapy
Overall survival
Incidence of serious adverse event
Efficacy of preemptive therapy using anti-HBV nucleoside analogue
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Histologically confirmed B-cell non-Hodgkin's lymphoma
2)CD20-positive
3)Seropositive for hepatitis B virus core antibody (HBc-Ab+) and/or hepatitis B surface antibody (HBs-Ab+) in patients with seronegativity for hepatitis B surface antigen(HBsAg-)
4)No prior systemic chemotherapy
5)Planned to be treated with 6-8 courses of systemic chemotherapy containing rituximab plus steroid such as R-CHOP, R-CVP,R-THP-COP and R-C-MOPP
(Regardless of administration schedule of rituximab)
6)20<=age<=79
7)ECOG PS 0-2
8)Normal hepatic, renal, cardiac and pulmonary function
9)Written informed consent by the patient
Key exclusion criteria
1)Isolated seropositivity for hepatitis B surface antibody (HBs-Ab+) in patients with a history of vaccination for hepatitis B virus
2)Seropositive to HCV
3)Seropositive to HIV
4)Liver cirrhosis
5)Serious infection
6)Planned to be treated with dialysis
7)Active coronary artery disease, cardiomyopathy, heart failure or arrhythmia
8)Have a history of glaucoma
9)Diabetes mellitus requiring insulin
10)Double cancer
11)Pregnant or lactating
12)Planned to be treated with hematopoietic stem-cell transplantation (autologous or allogeneic) on enrollment
13)Treated with major tranquilizer or antidepressant
14)Treated continuously with systemic steroids over 10mg per day (>10mg/day)
15)Plan to move house or to be transferred to another hospital within 1.5 years(have difficulty in serial HBV-DNA monitoring for 1.5 years)
16)Other conditions considered inappropriate by a physician
Target sample size
321
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Kusumoto |
Organization
Nagoya City University Graduate School of
Medical Sciences
Division name
Hematology and Oncology
Zip code
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8738
kusshan@rb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Kusumoto |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Hematology and Oncology
Zip code
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8738
Homepage URL
http://www.c-shot.or.jp/study/0802/outline/
kusshan@rb3.so-net.ne.jp
Sponsor or person
Institute
Nagoya City University Hospital
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
NPO Center for Supporting Hematology-Oncology Trials (C-SHOT)
SRL,Inc.
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
| 2008 | Year | 08 | Month | 11 | Day |
Related information
URL releasing protocol
http://www.c-shot.or.jp/study/0802/outline/
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/25935551
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
| 2008 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Correlative study by using preserved specimen
1)HBV-DNA measurement based on real-time PCR assay with ultra-high sensitivity
2)Serum marker measurement of HBV:HBsAg, HBV core-related antigen, HBc-Ab, HBs-Ab
3)Sequence analysis of HBV genes in cases with reactivation in a cohort
4)Mutation analysis of HBV genes in cases with reactivation in a cohort
Management information
Registered date
| 2008 | Year | 08 | Month | 05 | Day |
Last modified on
| 2019 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001562
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
