UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033757 |
|---|---|
| Receipt number | R000038506 |
| Scientific Title | Impact of sarcopenia in lenvatinib treatment for hepatocellular carcinoma; A prospective observational study |
| Date of disclosure of the study information | 2018/08/16 |
| Last modified on | 2022/08/20 17:03:46 |
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Basic information
Public title
Impact of sarcopenia in lenvatinib treatment for hepatocellular carcinoma; A prospective observational study
Acronym
Impact of sarcopenia in lenvatinib treatment for hepatocellular carcinoma; A prospective observational study
Scientific Title
Impact of sarcopenia in lenvatinib treatment for hepatocellular carcinoma; A prospective observational study
Scientific Title:Acronym
Impact of sarcopenia in lenvatinib treatment for hepatocellular carcinoma; A prospective observational study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarifty the impact of sarcopenia in lenvatinib treatment for hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Overall survival
Objective response
Time to progression Child-Pugh B
Adverse event
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
1)HCC diagnosed by typical findings of radiological findings or histologically proven by biopsy
2)No indications for hepatic surgical resection and radiofrequency ablation
3)Measurable lesion detected
4)Child-Pugh class A
5)Performance status 0-1
6)adequate bone marrow
7)adequate renal function
Key exclusion criteria
1)Child-Pugh class B or C
2)Performance status 2 or more
3)Patients with obvious invasion of the bile duct, or invasion at the main portal vein
4)Patients with 50% or higher liver occupation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hatanaka |
Organization
Saiseikai Maebashi Hospital
Division name
Department of Gastroenterology
Zip code
371-0821
Address
Kamishinden-machi 564-1, Maebashi, Gunma
TEL
027-252-6011
hatanaka@qk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Hatanaka |
Organization
Saiseikai Maebashi Hospital
Division name
Saiseikai Maebashi Hospital
Zip code
371-0821
Address
Kamishinden-machi 564-1, Maebashi, Gunma
TEL
027-252-6011
Homepage URL
hatanaka@qk9.so-net.ne.jp
Sponsor or person
Institute
Saiseikai Maebashi Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
The institutional review board
Address
Kamishinden-machi 564-1, Maebashi, Gunma
Tel
027-252-6011
te-yoshinaga@maebashi.saiseikai.or.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
| 2018 | Year | 08 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 08 | Month | 15 | Day |
Last modified on
| 2022 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038506
