UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055500 |
|---|---|
| Receipt number | R000063360 |
| Scientific Title | The Usefulness of iTACT-HBcrAg Monitoring in Detecting HBV Reactivation Among HBV-resolved Patients with Hematological Tumors: a prospective multicenter observational study |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/09/13 17:39:15 |
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Basic information
Public title
The Usefulness of iTACT-HBcrAg Monitoring in Detecting HBV Reactivation Among HBV-resolved Patients with Hematological Tumors: a prospective multicenter observational study
Acronym
iTACT - HBV study
Scientific Title
The Usefulness of iTACT-HBcrAg Monitoring in Detecting HBV Reactivation Among HBV-resolved Patients with Hematological Tumors: a prospective multicenter observational study
Scientific Title:Acronym
iTACT - HBV study
Region
| Japan |
Condition
Condition
Hematological Tumors where the doctor considers there to be a high risk of HBV reactivation
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To perform iTACT-HBcrAg monitoring on the same day as HBV-DNA monitoring and evaluate the utility of iTACT-HBcrAg monitoring as a potential replacement for HBV-DNA monitoring in a prospective observational study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of iTACT-HBcrAg monitoring
Key secondary outcomes
1) HBV reactivation rate
2) Incidence rate of HBV reactivation-related liver damage/hepatitis
3) Specificity of iTACT-HBcrAg
4) Rate of HBs antibody positivity
5) Success rate of iTACT-HBsAg monitoring (ancillary study)
6) Specificity of iTACT-HBsAg (ancillary study)
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) Having a history of past HBV infection (HBc antibody-positive and/or HBs antibody-positive among HBs antigen-negative cases). However, cases with HBs antibody positivity alone and a history of HBV
vaccination are excluded.
2) The attending physician judges the patient to be at high risk of HBV reactivation, and the patient is either scheduled for treatment of a hematologic disease or is within 4 weeks of starting treatment. The type of hematologic disease or treatment is not specified. As a reference, treatments expected to carry a high risk of HBV reactivation include:
- Anti-CD20 monoclonal antibody therapy and steroid combination chemotherapy
- Initial or salvage chemotherapy for lymphoid malignancies (such as malignant lymphoma, multiple myeloma, acute and chronic lymphocytic leukemia)
- Autologous or allogeneic hematopoietic stem cell transplantation
- Cellular immunotherapy (such as CAR-T cell therapy or bispecific antibodies)
3) Plans are in place for HBV reactivation prevention through HBV-DNA monitoring as recommended by the Japan Society of Hepatology guidelines.
4) A history of HBV reactivation (defined as HBV-DNA of 1.3 Log IU/mL or higher) is irrelevant. Patients with a history of nucleotide analogue therapy for HBV reactivation are also eligible for enrollment.
5) Re-enrollment is permitted for cases where the 1.5-year follow-up period has been completed.
Key exclusion criteria
1) The pre-enrollment HBV-DNA level is 1.3 Log IU/mL or higher (if measured at the enrolling facility within 4 weeks prior to enrollment).
2) The diagnosis of previous HBV reactivation occurred within 12 months prior to enrollment.
3) There is a history of nucleotide analogue administration, and it has been within 6 months since its discontinuation.
4) Nucleotide analogue therapy is being administered at the time of enrollment.
5) It is clearly impossible to plan for a 1.5-year follow-up at the enrolling facility after enrollment.
Target sample size
375
Research contact person
Name of lead principal investigator
| 1st name | Yasuhito |
| Middle name | |
| Last name | Tanaka |
Organization
Kumamoto University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
860-8556
Address
1-1-1 Honjo Chuo ku, Kumamoto, Kumamoto, Japan
TEL
096-373-5150
ytanaka@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiro |
| Middle name | |
| Last name | Tatetsu |
Organization
Kumamoto University Hospital
Division name
Department of Hematology, Rheumatology and Infectious Diseases
Zip code
860-8556
Address
1-1-1 Honjo Chuo ku, Kumamoto, Kumamoto, Japan
TEL
096-363-5156
Homepage URL
tatetsu@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto 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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Life Sciences, Kumamoto University
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
Tel
096-373-5657
ski-shien@jimu.kumamoto-u.ac.jp
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
愛知県がんセンター（愛知県）、、 今村総合病院（鹿児島県）、 永寿総合病院（東京都）、 大分大学医学部附属病院(大分県）、 大分県立病院(大分県）、 大阪大学大学院 医学系研究科(大阪府）、 神奈川県立がんセンター(神奈川県）、 金沢大学附属病院(石川県）、 岐阜大学医学部附属病院(岐阜県）、 九州医療センター(福岡県）、 九州大学病院(福岡県）、 京都第一赤十字病院(京都府）、 京都府立医科大学附属病院(京都府）、 近畿大学病院(大阪府）、 くまもと森都総合病院(熊本県）、 倉敷中央病院(岡山県）、 群馬県立がんセンター(群馬県）、 慶應義塾大学病院(東京都）、 公益財団法人がん研究会有明病院(東京都）、 国立がん研究センター中央病院(東京都）、 国立病院機構熊本医療センター(熊本県）、 国立病院機構四国がんセンター(愛媛県）、 国立病院機構渋川医療センター(群馬県）、 国立病院機構長崎医療センター(長崎県）、 埼玉医科大学国際医療センター(埼玉県）、 埼玉医科大学総合医療センター(埼玉県）、 佐賀大学医学部附属病院(佐賀県）、 佐世保市総合医療センター(長崎県）、 島根大学医学部附属病院(島根県）、 順天堂大学医学部附属練馬病院(東京都）、 新百合ヶ丘総合病院(神奈川県）、 天使病院(北海道）、 東海大学医学部(神奈川県）、 東京慈恵会医科大学附属第三病院(東京都）、 東京慈恵会医科大学附属病院(東京都）、 東北大学病院(宮城県）、 徳島大学病院(徳島県）、 長崎大学病院(長崎県）、 名古屋市立大学病院(愛知県）、 名古屋大学医学部附属病院(愛知県）、 日本医科大学付属病院(東京都）、 浜田医療センター(島根県）、 兵庫県立尼崎総合医療センター(兵庫県）、 北海道大学病院(北海道）、 宮崎大学医学部附属病院(宮崎県）、 山形大学医学部附属病院(山形県）、 和歌山県立医科大学附属病院(和歌山県）、 JCHO熊本総合病院(熊本県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2024 | Year | 09 | Month | 13 | Day |
Last modified on
| 2024 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063360
