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 2024/02/05 14:36:11

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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 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

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

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

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

2024 Year 02 Month 05 Day



Link to view the page

Value
https://center6.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