UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036397 |
|---|---|
| Receipt number | R000041463 |
| Scientific Title | Lenvatinib-induced thyroid abnormalities in unresectable hepatocellular carcinoma |
| Date of disclosure of the study information | 2019/04/03 |
| Last modified on | 2019/04/03 13:13:11 |
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Basic information
Public title
Lenvatinib-induced thyroid abnormalities in unresectable hepatocellular carcinoma
Acronym
Lenvatinib-induced thyroid abnormalities in unresectable hepatocellular carcinoma
Scientific Title
Lenvatinib-induced thyroid abnormalities in unresectable hepatocellular carcinoma
Scientific Title:Acronym
Lenvatinib-induced thyroid abnormalities in unresectable hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aimed to clarify the frequency and timing of thyroid abnormalities in lenvatinib for unresectable HCC. Toward this goal, we retrospectively collected data and compared the incidence and time of onset of thyroid dysfunction in Japanese patients with unresectable HCC treated with lenvatinib.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Collect and evaluate data on thyroid function changes, duration of treatment, treatment effects, turning points, causes of death.
Key secondary outcomes
1) General clinical examination: Collect data at the time of diagnosis, regular visit, and the end of treatment for treatment.
2) Collect data on age, gender, treatment start date, Child-Pugh classification, and complications.
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 who received lenvatinib treatment for unresectable hepatocellular carcinoma.
Key exclusion criteria
There are no exclusion criteria as they are for diagnosed patients.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Hiasa |
Organization
Ehime University Graduate School of Medicine
Division name
Departments of Gastroenterology and Metabology
Zip code
7910295
Address
Toon City, Ehime, Japan
TEL
089-960-5308
hiasa@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Koizumi |
Organization
Ehime University Graduate School of Medicine
Division name
Departments of Gastroenterology and Metabology
Zip code
7910295
Address
Toon City, Ehime, Japan
TEL
089-960-5308
Homepage URL
ykoizumi@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine, Departments of Gastroenterology and Metabology
Institute
Department
Personal name
Funding Source
Organization
none
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
Certified Review Board Ehime University
Address
Toon city, Ehime, Japan
Tel
089-960-5914
cttc@m.ehime-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 | 04 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Based on the accumulated data, data analysis is evaluated using descriptive statistics, Kaplan-Meier method, log rank test and logistic analysis.
Management information
Registered date
| 2019 | Year | 04 | Month | 03 | Day |
Last modified on
| 2019 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041463
| 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 |
