UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035090 |
|---|---|
| Receipt number | R000040003 |
| Scientific Title | Elucidation of drug resistance mechanism at metastasis of liver cancer and bile duct cancer |
| Date of disclosure of the study information | 2018/12/03 |
| Last modified on | 2019/06/07 10:51:39 |
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Basic information
Public title
Elucidation of drug resistance mechanism at metastasis of liver cancer and bile duct cancer
Acronym
Elucidation of drug resistance mechanism at metastasis of liver cancer and bile duct cancer
Scientific Title
Elucidation of drug resistance mechanism at metastasis of liver cancer and bile duct cancer
Scientific Title:Acronym
Elucidation of drug resistance mechanism at metastasis of liver cancer and bile duct cancer
Region
| Japan |
Condition
Condition
Liver cancer, Bile duct cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate of correlation between pharmacokinetic factor and cancer metastasis factor in liver and bile duct cancer patients.
Basic objectives2
Others
Basic objectives -Others
The second objective of this study is to evaluate the difference in gene expression between primary and metastatic sites of cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of gene expression and correlation between each genes expression in cancer tissues and normal tissues of patients with liver cancer and bile duct cancer.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1: Patient who have primary liver or bileduct cancer and no cancer chemotherapy in the past.
2: Patients who received removal surgery of liver or bileduct cancer in Kanazawa University Hospital.
3: Patients who received sufficient explanation of this study, on a sufficient understanding, written informed consent.
Key exclusion criteria
Patients who are judged as being inappropriate for this study by their medical doctor
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takuo |
| Middle name | |
| Last name | Ogihara |
Organization
Graduate School of Pharmaceutical Sciences Takasaki University of Health and Welfare
Division name
Laboratory of Clinical Pharmacokinetics
Zip code
370-0033
Address
60 Nakaorui-machi, Takasaki-shi, Gunma
TEL
027-352-1180
togihara@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuo |
| Middle name | |
| Last name | Ogihara |
Organization
Graduate School of Pharmaceutical Sciences Takasaki University of Health and Welfare
Division name
Laboratory of Clinical Pharmacokinetics
Zip code
370-0033
Address
60 Nakaorui-machi, Takasaki-shi, Gunma
TEL
027-352-1180
Homepage URL
togihara@takasaki-u.ac.jp
Sponsor or person
Institute
Graduate School of Pharmaceutical Sciences Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ERC at Takasaki University of Health and Welfare
Address
60 Nakaorui-machi, Takasaki-shi, Gunma
Tel
027-352-1290
mune@takasaki-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
高崎健康福祉大学(群馬県)、金沢大学附属病院(石川県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study is prospective observational research which evaluate gene expression of pharmacokinetic factor and cancer metastasis factor in resected liver and bile duct cancer.
We evaluate the correlation of expression level between each gene and clarify the involvement of metastasis regulators and pharmacokinetics regulators.
Management information
Registered date
| 2018 | Year | 11 | Month | 30 | Day |
Last modified on
| 2019 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040003
