UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044027 |
|---|---|
| Receipt number | R000050271 |
| Scientific Title | Molecular pathological epidemiology research on pancreatic tumors |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2022/01/26 16:37:09 |
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Basic information
Public title
Molecular pathological epidemiology research on pancreatic tumors
Acronym
MPE of pancreatic tumors
Scientific Title
Molecular pathological epidemiology research on pancreatic tumors
Scientific Title:Acronym
MPE of pancreatic tumors
Region
| Japan |
Condition
Condition
Pancreatic tumors
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To elucidate pathogenesis of development and progression of pancreatic tumors through analyzing epidemiological, clinical, pathological, and molecular characteristics and their associations with survival outcomes
Basic objectives2
Others
Basic objectives -Others
Retrospective analyses of data derived from a multicenter cohort
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Epidemiological, clinical, pathological, and molecular characteristics and survival outcomes (e.g., disease-free survival, overall survival)
Key secondary outcomes
Response to chemotherapy, patterns of postoperative recurrence, and others
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 underwent endoscopic or percutaneous biopsy or surgical resection of pancreatic tumors
Key exclusion criteria
Patients who researchers consider as ineligible or those who opt out of participant in this study
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Hamada |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo City, Tokyo
TEL
03-3815-5411
hamada-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Hamada |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo City, Tokyo
TEL
03-3815-5411
Homepage URL
hamada-tky@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Ethical committee at Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo City, Tokyo
Tel
03-5841-0818
-
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-1106
Org. issuing International ID_1
Japanese Foundation for Cancer Research
Study ID_2
20200341
Org. issuing International ID_2
Keio University
IND to MHLW
Institutions
Institutions
がん研究会有明病院(東京都)、慶應義塾大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will collect clinical data from medical charts that were recorded in clinical practice. For molecular pathological analyses, we will use formalin-fixed paraffin-embedded tissue samples of pancreatic tumors (or relevant lesions including metastatic lesions and pre-malignant lesions) that have been obtained via endoscopic or percutaneous biopsy or surgical resection in clinical practice. Participants will not have any additional experiences or burden related to this study.
Management information
Registered date
| 2021 | Year | 04 | Month | 24 | Day |
Last modified on
| 2022 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050271
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
