UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016431 |
|---|---|
| Receipt number | R000019080 |
| Scientific Title | Analysis of gene polymorphism in hepatocellular carcinoma patients treated with sorafenib therapy |
| Date of disclosure of the study information | 2015/02/06 |
| Last modified on | 2023/08/16 11:37:44 |
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Basic information
Public title
Analysis of gene polymorphism in hepatocellular carcinoma patients treated with sorafenib therapy
Acronym
AGHCs
Scientific Title
Analysis of gene polymorphism in hepatocellular carcinoma patients treated with sorafenib therapy
Scientific Title:Acronym
AGHCs
Region
| Japan |
Condition
Condition
Heoatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We investigated the relationship with side effects and prognosis according to gene polymorphism in hepatocellular carcinoma patients treated with sorafenib.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between side effects and gene polymorphism
Key secondary outcomes
Relationship between prognosis and gene polymorphism
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sorafenib therapy
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. Clinical diagnosed hepatocellular carcinoma patients treated with sorafenib therapy, discontinued sorafenib therapy, or intended to treat with sorafenib therapy
2. Extrahepatic metastasis is no object.
3. Child-Pugh class A-B(7)
4. Good reserved function of main organs (bone marrow, kidney, and heart)
(1) WBC >/= 2000/mm3
(2) Plt >/= 5x104/mm3
(3) Hb >/= 8.0g/dL
(4) creatinine < 2mg/dL
(5) Heart function except exclusion criteria
5. Informed consentwas obtained.
Key exclusion criteria
1. Following serous comlicating diseases, except for chronic hepatitis and liver cirrhosis:
a) Renal failure with blood or peritoneal dialysis
b) Heart failure >/= NYHA class III, serious ischemic herat disease, and serious arhythmia
c) uncontrolled hypertension
d) brain tumors
2. Past or present history of malignant tumors except for HCC
3. Past history of allergy in iodine or contrast agent
4. Inadequate patient judged by a doctor
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Yamasaki |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Oncology and Laboratory Medicine
Zip code
755-8505
Address
1-1-1 Minami Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2336
t.yama@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Saeki |
| Middle name | |
| Last name | Issei |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
755-8505
Address
1-1-1 Minami Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2241
Homepage URL
issaeki@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Hospital
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
Center For Clinical Research.Yamaguchi University Hospital
Address
1-1-1 Minami Kogushi, Ube, Yamaguchi 755-8505, Japan
Tel
0836-22-2428
me223@yamaguchi-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
| 2015 | Year | 02 | Month | 06 | 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
| 2014 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 03 | Day |
Last modified on
| 2023 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019080
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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