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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035090
Receipt No. R000040003
Official scientific title of the study 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 2018/11/30

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Basic information
Official scientific title of the study Elucidation of drug resistance mechanism at metastasis of liver cancer and bile duct cancer
Title of the study (Brief title) 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 Takuo Ogihara
Organization Graduate School of Pharmaceutical Sciences Takasaki University of Health and Welfare
Division name Laboratory of Clinical Pharmacokinetics
Address 60 Nakaorui-machi, Takasaki-shi, Gunma
TEL 027-352-1180
Email togihara@takasaki-u.ac.jp

Public contact
Name of contact person Takuo Ogihara
Organization Graduate School of Pharmaceutical Sciences Takasaki University of Health and Welfare
Division name Laboratory of Clinical Pharmacokinetics
Address 60 Nakaorui-machi, Takasaki-shi, Gunma
TEL 027-352-1180
Homepage URL
Email togihara@takasaki-u.ac.jp

Sponsor
Institute Graduate School of Pharmaceutical Sciences Takasaki University of Health and Welfare
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 10 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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040003

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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