UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037380 |
|---|---|
| Receipt number | R000042596 |
| Scientific Title | Correlation between mass of muscle and effect of lenvatinib in patients with hepatocellular carcinoma |
| Date of disclosure of the study information | 2019/07/15 |
| Last modified on | 2020/02/17 20:57:12 |
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Basic information
Public title
Correlation between mass of muscle and effect of lenvatinib in patients with hepatocellular carcinoma
Acronym
Correlation between mass of muscle and effect of lenvatinib
Scientific Title
Correlation between mass of muscle and effect of lenvatinib in patients with hepatocellular carcinoma
Scientific Title:Acronym
Correlation between mass of muscle and effect of lenvatinib
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate if body skeletal muscle mass were correlated with toxicity and survival in patients with advanced HCC treated with lenvatinib.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The influences of SMI on the occurrence of drug withdral due to severe adverse events (AEs).
Key secondary outcomes
We also investigated the influences of SMI on TTF (Time to treatment failure) and Overall survival(OS).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with unresectable HCC and the following features: i) The presence of distant metastases;
ii) refractory response to previous transcatheter arterial therapies for HCC;
iii) unsuitability for transcatheter arterial therapies due to anatomical reasons;
iv) vascular invasion such as tumor thrombus in the portal vein.
Key exclusion criteria
i) child-pugh class C,
ii) poorly controlled ascites,
iii) severe renal dysfunction
iv) malignancy except hepatocellular carcinoma
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Haruki |
| Middle name | |
| Last name | Uojma |
Organization
Kitasato University school of medicine
Division name
Department of gastroenterology
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0375, Japan
TEL
042-778-8111
kiruha@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Uojima |
Organization
Kitasato University school of medicine
Division name
Department of gastroenterology
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0375, Japan
TEL
042-778-8111
Homepage URL
kiruha@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University school of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University school of medicine, Institutional Review Board
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0375, Japan
Tel
042-778-8111
rinrib@med.kitasato-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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 15 | 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
| 2019 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
retrospective study
Management information
Registered date
| 2019 | Year | 07 | Month | 15 | Day |
Last modified on
| 2020 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042596
