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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000022960
Receipt No. R000026449
Scientific Title Genomic biomarker research for advanced pancreatic cancer and neuroendocrine tumor.
Date of disclosure of the study information 2016/06/30
Last modified on 2016/06/30

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Basic information
Public title Genomic biomarker research for advanced pancreatic cancer and neuroendocrine tumor.
Acronym Genomic biomarker research for advanced pancreatic cancer and neuroendocrine tumor.
Scientific Title Genomic biomarker research for advanced pancreatic cancer and neuroendocrine tumor.
Scientific Title:Acronym 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

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) 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
1st name
Middle name
Last name Kentaro Sudo
Organization Chiba Cancer Center
Division name Gastroenterology
Zip code
Address 666-2 Nitona-cho, Chuo-ku, Chiba, Japan
TEL 043-264-5431
Email ksudo@chiba-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Sudo
Organization Chiba Cancer Center
Division name Gastroenterology
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
Date of protocol fixation
2008 Year 11 Month 10 Day
Date of IRB
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

Other
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

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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