UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022960 |
|---|---|
| Receipt number | 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 15:54:27 |
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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
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
ksudo@chiba-cc.jp
Sponsor or person
Institute
Chiba Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026449
