UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017958 |
|---|---|
| Receipt number | R000020813 |
| Scientific Title | Developing a diagnostic method for pancreatic cancer at the very early stage |
| Date of disclosure of the study information | 2015/06/18 |
| Last modified on | 2023/12/06 17:24:44 |
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Basic information
Public title
Developing a diagnostic method for pancreatic cancer at the very early stage
Acronym
Developping a diagnostic method for pancreatic cancer at the very early stage
Scientific Title
Developing a diagnostic method for pancreatic cancer at the very early stage
Scientific Title:Acronym
Developping a diagnostic method for pancreatic cancer at the very early stage
Region
| Japan |
Condition
Condition
Intraductal papillary mucinous neoplasm (IPMN), Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Developing the diagnostic method for pancreatic cancer at the very early stage
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Better diagnostic performance is obtained than existing tumor markers
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
The consent for registration is obtained
Key exclusion criteria
The consent for registration is not understood
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Hagihara |
Organization
Osaka City University
Division name
Department of Hepatology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3811
hagy@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Hagihara |
Organization
Osaka City University
Division name
Department of Hepatology
Zip code
545-8585
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3811
Homepage URL
hagy@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
MHLW/AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics, Osaka City University
Address
1-2-7, Asahi-machi, Abeno-ku, Osaka
Tel
06-6645-3434
ethics@med.osaka-cu.ac.jp
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
大阪市立大学（大阪府）、京都大学（京都府）、国立がん研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 18 | 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
| 2014 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Developing the diagnotic method for pancreatic cancer at very early stage, utilizing the relation between expression of micro RNA and status of DNA methylation
Management information
Registered date
| 2015 | Year | 06 | Month | 18 | Day |
Last modified on
| 2023 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020813
