UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034611 |
|---|---|
| Receipt number | 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 | 2024/12/04 09:37:24 |
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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
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Maesaka |
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
k.maesaka@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
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
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
| 2024 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038483
