UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006840 |
|---|---|
| Receipt number | R000008075 |
| Scientific Title | Research of gemcitabine sensitivity in pancreatic cancer. |
| Date of disclosure of the study information | 2011/12/08 |
| Last modified on | 2016/06/08 17:23:02 |
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Basic information
Public title
Research of gemcitabine sensitivity in pancreatic cancer.
Acronym
Research of gemcitabine sensitivity in pancreatic cancer.
Scientific Title
Research of gemcitabine sensitivity in pancreatic cancer.
Scientific Title:Acronym
Research of gemcitabine sensitivity in pancreatic cancer.
Region
| Japan |
Condition
Condition
Advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will observe the relationship between the level of phosphorylated heat shock protein 27 (HSP27) obtained from human pancreatic cancer by EUS-FNA and the sensitivity to gemcitabine (GEM) in order to find god prognostic marker.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate and prognosis of chmotherapy with GEM.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Chemotherapy including gemcitabine.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Advanced pancreatic cancer diagnosed by EUS-FNA.
Key exclusion criteria
Advanced pancreatic cancer could not be diagnosed by EUS-FNA.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Gifu University
Division name
Dept. of Gastroenterology
Zip code
Address
1-1 Yanagido, Gifu 501-1194, Japan
TEL
058-230-6308
yasudaic@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Gifu University
Division name
Dept. of Gastroenterology
Zip code
Address
1-1 Yanagido, Gifu 501-1194, Japan
TEL
058-230-6308
Homepage URL
yasudaich@gmail.com
Sponsor or person
Institute
Gifu University
Dept. of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology of Japan.
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2011 | Year | 12 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 05 | Day |
Last modified on
| 2016 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008075
