UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006253 |
|---|---|
| Receipt number | R000007402 |
| Scientific Title | The prediction for efficacy of gemcitabine postoperative adjuvant chemotherapy in pancreatic cancer by the expression analysis of the metabolic enzymes and transporters using LC-MS/MS Quantitative Targeted Proteomics |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2016/12/16 16:39:15 |
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Basic information
Public title
The prediction for efficacy of gemcitabine postoperative adjuvant chemotherapy in pancreatic cancer by the expression analysis of the metabolic enzymes and transporters using LC-MS/MS Quantitative Targeted Proteomics
Acronym
The prediction for the efficacy of gemcitabine postoperative adjuvant chemotherapy in pancreatic cancer using LC-MS/MS Quantitative Targeted Proteomics
Scientific Title
The prediction for efficacy of gemcitabine postoperative adjuvant chemotherapy in pancreatic cancer by the expression analysis of the metabolic enzymes and transporters using LC-MS/MS Quantitative Targeted Proteomics
Scientific Title:Acronym
The prediction for the efficacy of gemcitabine postoperative adjuvant chemotherapy in pancreatic cancer using LC-MS/MS Quantitative Targeted Proteomics
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to analyze the efficacy of LC-MS/MS target proteomics in the prediction of gemcitabin efficacy in the postoperative adjuvant chemotherapy in pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival, progression free survival, expression level of metabolic enzymes and transporters
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who administered curative resection(R0 and R1) for pancreatic cancer (invasive ductal carcinoma)
Key exclusion criteria
1. patients who administered non-curative resection (R2)
2. pancreatic cancer expect for invasive ductal carcinoma
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Unno |
Organization
Tohoku university
Division name
Hepato-biliary pancreatic surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideo Ohtsuka |
Organization
Tohoku university
Division name
Hepato-biliary pancreatic surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
Homepage URL
ohtsuka@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Hepato-biliary pancreatic surgery
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
The Ministry of Education, Culture, Sports, Science and Technology(MEXT)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tohoku University
Membrane transport and drug targeting laboratory
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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | 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
The aim of this study is to analyze the efficacy of LC-MS/MS target proteomics in the prediction of gemcitabin efficacy in the postoperative adjuvant chemotherapy in pancreatic cancer. The over all survival, progression free survival, and expression level of metabolic enzymes and transporters will be analyzed.
Management information
Registered date
| 2011 | Year | 08 | Month | 30 | Day |
Last modified on
| 2016 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007402
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| Registered date | File name |
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| Registered date | File name |
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