UMIN-CTR Clinical Trial

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
Email	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
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)

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040003