UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041974 |
|---|---|
| Receipt number | 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 | 2024/06/17 10:44:52 |
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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
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
knakaoka@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
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
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
Open public recruiting
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
| 2028 | 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
| 2024 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047189
