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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034611
Receipt No. R000038483
Scientific Title A prospective multicenter observational study of patients treated with systemic chemotherapy for hepatocellular carcinoma
Date of disclosure of the study information 2018/10/23
Last modified on 2019/04/24

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Basic information
Public title A prospective multicenter observational study of patients treated with systemic chemotherapy for hepatocellular carcinoma
Acronym Systemic chemotherapy for hepatocellular carcinoma: a prospective multicenter observational study
Scientific Title A prospective multicenter observational study of patients treated with systemic chemotherapy for hepatocellular carcinoma
Scientific Title:Acronym Systemic chemotherapy for hepatocellular carcinoma: a prospective multicenter 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 The aim of this study is to investigate effective biomarkers for predictive factors of therapeutic effect by evaluating patient backgrounds, anti-tumor effects, and long-term prognosis in patients treated with systemic chemotherapy for hepatocellular carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Anti-tumor effects and long-term prognosis in patients treated with systemic chemotherapy for hepatocellular carcinoma
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients with 20 years of age and older
(2) Patients expected to survive for more than 12 weeks
(3) Patients diagnosed as typical hepatocellular carcinoma by histological/cytological diagnosis or imaging diagnosis by dynamic CT (or MRI)
(4) Patients who are difficult for surgical resection or locoregional therapies and are indicated for systemic chemotherapy
(5) Patients with Eastern Cooperative Oncology Group performance status score of 0 or 1
(6) No contraindication to systemic chemotherapy, per the approved package insert of each medication
Key exclusion criteria (1) Patients who do not give informed consent
(2) Patients who are not judged to be eligible for participation in this study by researchers
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Takehara
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 565-0871
Address Yamadaoka 2-2, Suita city, Osaka
TEL 06-6879-3621
Email takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Ryotaro
Middle name
Last name Sakamori
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 565-0871
Address Yamadaoka 2-2, Suita city, Osaka
TEL 06-6879-3621
Homepage URL
Email sakamori@gh.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka University Clinical Research Review Committee
Address Yamadaoka 2-2, Suita city, Osaka
Tel 06-6210-8296
Email rinri@hp-crc.med.osaka-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
2018 Year 10 Month 23 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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 23 Day
Date of IRB
2018 Year 10 Month 23 Day
Anticipated trial start date
2018 Year 10 Month 23 Day
Last follow-up date
2023 Year 07 Month 31 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 10 Month 23 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038483

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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