UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013053 |
|---|---|
| Receipt number | R000015194 |
| Scientific Title | miRNA analysis study using a peptide vaccine for pancreatic cancer after surgery clinical trial subjects serum |
| Date of disclosure of the study information | 2014/02/03 |
| Last modified on | 2016/08/24 10:12:03 |
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Basic information
Public title
miRNA analysis study using a peptide vaccine for pancreatic cancer after surgery clinical trial subjects serum
Acronym
miRNA analysis study using a peptide vaccine for pancreatic cancer after surgery clinical trial subjects serum
Scientific Title
miRNA analysis study using a peptide vaccine for pancreatic cancer after surgery clinical trial subjects serum
Scientific Title:Acronym
miRNA analysis study using a peptide vaccine for pancreatic cancer after surgery clinical trial subjects serum
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the biomarker search for the efficacy and safety of the peptide vaccine therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The patient serum are measured comprehensively by the miRNA array analysis. This study comprehensively analyzes the expression in the specimens for all of about 1700 human miRNA (as of April 2012) which are registered in the miRBase which is a database of miRNA. Measurement method performs by next-generation sequencing in the research institutes, and we perform the extraction of RNA from the specimen, and the measurement of miRNA using the 3D-Gene ® miRNA oligo chip24.
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
Patients with the consent of the peptide vaccine clinical research pancreatic cancer after surgery and the postoperative GEM clinical research at the Wakayama Medical University Hospital
Key exclusion criteria
Not obtained the consent
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Ishii |
Organization
National Institutes of Biomedical Innovation,Health and Nutrition
Division name
Laboratory of Adjuvant Innovation
Zip code
Address
7-6-8 Asagi Saito Ibaraki-City Osaka
TEL
072-641-8043
kenishii@biken.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Ishii |
Organization
National Institutes of Biomedical Innovation,Health and Nutrition
Division name
Laboratory of Adjuvant Innovation
Zip code
Address
7-6-8 Asagi Saito Ibaraki-City Osaka
TEL
072-641-8043
Homepage URL
kenishii@biken.osaka-u.ac.jp
Sponsor or person
Institute
National Institutes of Biomedical Innovation,Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Wakayama Medical University Hospital
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
| 2014 | Year | 02 | Month | 03 | 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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | 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
Sample
Serum from patients with the consent of the peptide vaccine clinical research pancreatic cancer after surgery and the postoperative GEM clinical research at the Wakayama Medical University Hospital and clinical information of the patients without individual date are sent for National Institute of Biomedical Innovation with state that has been granted the only number of each patient to be granted in this clinical study
Management information
Registered date
| 2014 | Year | 02 | Month | 03 | Day |
Last modified on
| 2016 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015194
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
