UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective study of HBV reactivation following chemotherapy for solid tumor
Acronym	A retrospective study of HBV reactivation following chemotherapy for solid tumor
Scientific Title	A retrospective study of HBV reactivation following chemotherapy for solid tumor
Scientific Title:Acronym	A retrospective study of HBV reactivation following chemotherapy for solid tumor
Region	Japan

Condition
Condition	solid tumor
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess HBV reactivation following chemotherapy for solid tumor.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HBV reactivation rate
Key secondary outcomes

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	solid tumor patients treated by systemic chemotherapy since September 2012
Key exclusion criteria	non
Target sample size	1088

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takeshi Kotake
Organization	Kobe City Medical Center General Hospital
Division name	medical oncology
Zip code
Address	2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL	078-302-4321
Email	tkkotake@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Takeshi Kotake
Organization	Kobe City Medical Center General Hospital
Division name	medical oncology
Zip code
Address	2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL	078-302-4321
Homepage URL
Email	tkkotake@gmail.com

Sponsor
Institute	Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization	Kobe City Medical Center General Hospital
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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	2015 Year 04 Month 30 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	2015 Year 04 Month 10 Day
Date of IRB	2015 Year 04 Month 10 Day
Anticipated trial start date	2015 Year 04 Month 10 Day
Last follow-up date	2015 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	retrospective study

Management information
Registered date	2015 Year 04 Month 28 Day
Last modified on	2019 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020091