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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036397
Receipt No. 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

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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
Email 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
Email ykoizumi@m.ehime-u.ac.jp

Sponsor
Institute Ehime University Graduate School of Medicine, Departments of Gastroenterology and Metabology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041463

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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