UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Genomic biomarker research for advanced pancreatic cancer and neuroendocrine tumor.
Title of the study (Brief title)	Genomic biomarker research for advanced pancreatic cancer and neuroendocrine tumor.
Region	Japan

Condition
Condition	pancreatic cancer, pancreatic neuroendocrine tumor
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To develop a novel biomarker and pesonalized cancer treatment for unresectable pancreatic cancer and pancratic neuroendocrine tumor.
Basic objectives2	Others
Basic objectives -Others	1)Genomic biomarker research based on clinical information 2)Primary culture for drug sensitivity testing
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comprehensive genomic analysis compared with clinical information (e.g. response to chemotherapy, survival outcome, or clinical stage).
Key secondary outcomes

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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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with pancreatic cancer or pancreatic neuroendocrine tumor. 2) Patients with unresectable or recurrunt disease. 3) Patients who are planned to undergo a biopsy. 4) Written informed consent
Key exclusion criteria	1) Bleeding tendency 2) Patients who are judged to be inappropriate for the study participatin by the primary physician
Target sample size	230

Research contact person
Name of lead principal investigator	Kentaro Sudo
Organization	Chiba Cancer Center
Division name	Gastroenterology
Address	666-2 Nitona-cho, Chuo-ku, Chiba, Japan
TEL	043-264-5431
Email	ksudo@chiba-cc.jp

Public contact
Name of contact person	Kentaro Sudo
Organization	Chiba Cancer Center
Division name	Gastroenterology
Address	666-2 Nitona-cho, Chuo-ku, Chiba, Japan
TEL	043-264-5431
Homepage URL
Email	ksudo@chiba-cc.jp

Sponsor
Institute	Chiba Cancer Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 30 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2008 Year 11 Month 10 Day
Anticipated trial start date	2008 Year 11 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	1) Genomic biomarker research based on clinical information 2) Primary culture for drug testing

Management information
Registered date	2016 Year 06 Month 30 Day
Last modified on	2016 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026449