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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010000
Receipt No. R000011387
Scientific Title Prospective observational study to investigate the predictive factors on the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.
Date of disclosure of the study information 2013/02/08
Last modified on 2015/03/02

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Basic information
Public title Prospective observational study to investigate the predictive factors on the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.
Acronym Prospective observational study to investigate the predictive factors on the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.
Scientific Title Prospective observational study to investigate the predictive factors on the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.
Scientific Title:Acronym Prospective observational study to investigate the predictive factors on the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate the predictive factors on the efficacy of molecular targeting therapy for unresectable advanced hepatocellular carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The clinicopathological factors related to time to progression of unresectable advanced hepatocellular carcinoma.patients treated with sorafenib.
Key secondary outcomes The clinicopathological factors related to overall survival of unresectable advanced hepatocellular carcinoma patients treated with sorafenib.
The clinicopathological factors to predict serious adverse effects caused by sorafenib.

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 with unresectable advanced hepatocellular carcinoma who are to be treated with sorafenib and from whom written informed consent was obtained.
Key exclusion criteria Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 and pretreatment Child-Pugh score of 8 or more.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Namiki Izumi
Organization Musashino Red Cross Hospital
Division name Division of Gastroenterology and Hepatology
Zip code
Address 1-26-1, Kyonancho, Musashino, Tokyo
TEL 0422-32-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yukio Osaki
Organization Osaka Red Cross Hospital
Division name department of Gatroenterology and Hepatology
Zip code
Address 5-30, Fudegasaki-cho, Tennoji-ku, Osaka
TEL 06-6774-5111
Homepage URL
Email

Sponsor
Institute Japanese Red Cross Liver Study Group
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Division of Genome biology, Kinki University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 武蔵野赤十字病院, 大阪赤十字病院, その他全国赤十字病院

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2012 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 22 Day
Last follow-up date
2013 Year 10 Month 31 Day
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 01 Month 15 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information To investigate the predictive factors on the efficacy of sorafenib therapy for unresectable advanced hepatocellular carcinoma.
To perform genomic analyses on patients` tumor tissue obtained by liver biopsy before sorafenib administration, and to investigate biomarkers related with clinical course including OS, PFS and adverse effects.

Management information
Registered date
2013 Year 02 Month 08 Day
Last modified on
2015 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011387

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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