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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044027
Receipt No. R000050271
Scientific Title Molecular pathological epidemiology research on pancreatic tumors
Date of disclosure of the study information 2021/05/01
Last modified on 2021/04/25

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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 Keisuke
Middle name
Last name Tateishi
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
Email ktate-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
Email hamada-tky@umin.ac.jp

Sponsor
Institute Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Institute
Department

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
Email -

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
2021 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050271

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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