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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041974
Receipt No. R000047189
Scientific Title The genetic research of interaction and prognosis in the process of inflammation to carcinogenesis of biliary-pancreatic disease
Date of disclosure of the study information 2020/10/02
Last modified on 2020/10/02

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Basic information
Public title The genetic research of interaction and prognosis in the process of inflammation to carcinogenesis of biliary-pancreatic disease
Acronym The genetic research of interaction and prognosis in the process of inflammation to carcinogenesis of biliary-pancreatic disease
Scientific Title The genetic research of interaction and prognosis in the process of inflammation to carcinogenesis of biliary-pancreatic disease
Scientific Title:Acronym The genetic research of interaction and prognosis in the process of inflammation to carcinogenesis of biliary-pancreatic disease
Region
Japan

Condition
Condition biliary-pancreatic disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We aim to elucidate the universal or disease-specific mechanism of gastrointestinal carcinogenesis in the development and to detect it early and establish a Individual-specific treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Not applicable
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Pancreatic cancer, biliary tract cancer and its premalignant lesions over 20 years old.
Key exclusion criteria Patients who do not have written consent.
Other patients who are judged to be inappropriate as subjects by the research doctor
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Yoshiki
Middle name
Last name Hirooka
Organization Fujita Health University
Division name Department of Gastroenterology and Gastroenterological Oncology
Zip code 470-1192
Address 1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL +81562932324
Email yoshiki.hirooka@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Kazunori
Middle name
Last name Nakaoka
Organization Fujita Health University
Division name Department of Gastroenterology and Gastroenterological Oncology
Zip code 470-1192
Address 1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL +81562932324
Homepage URL
Email knakaoka@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Fujita Health University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fujita Health University
Address 1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
Tel +81562932865
Email yoshiki.hirooka@fujita-hu.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

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 02 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 Enrolling by invitation
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
2017 Year 04 Month 27 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information DNA and RNA are collected from blood, urine, stool or endoscopic specimens, and gene mutations and methylation are analyzed.

Management information
Registered date
2020 Year 10 Month 02 Day
Last modified on
2020 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047189

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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