UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042727
Receipt number R000048774
Scientific Title Searching for Personalized Disease Mechanisms for Primary Sclerosing Cholangitis Using Human Bile-Derived Bile Organoids
Date of disclosure of the study information 2021/04/01
Last modified on 2020/12/11 17:37:41

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Basic information

Public title

Study of primary sclerosing cholangitis using bile-derived organoids

Acronym

Bile Duct Organoid Research in Primary Sclerosing Cholangitis

Scientific Title

Searching for Personalized Disease Mechanisms for Primary Sclerosing Cholangitis Using Human Bile-Derived Bile Organoids

Scientific Title:Acronym

Study on the disease mechanism of organoid-induced primary sclerosing cholangitis

Region

Japan


Condition

Condition

Primary Sclerosing Cholangitis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Identifying new disease mechanisms in PSC using patient-derived bile-derived bile duct organoids.

Basic objectives2

Others

Basic objectives -Others

In order to find out the characteristic features of bile duct organoids in PSC, we will prepare bile-derived bile duct organoids in two groups of patients undergoing ERCP at our hospital, PSC patients and non-PSC patients, and analyze their morphological changes and inflammatory profiles in detail in vitro.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Identification of a new disease-specific mechanism using bile-derived bile duct organoids generated from PSC patients.

Key secondary outcomes

Changes in the morphology and inflammatory profile of bile-derived bile duct organoids among PSC patients or various diseases


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

Collect bile during ERCP for PSC patients

Interventions/Control_2

Collect bile during ERCP for non-PSC patients

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing ERCP for liver, bile duct, or pancreas disease at our hospital who understand the contents of this study and have given written consent to participate in the study.

Key exclusion criteria

Patients who have requested to be excluded from the study

The principal investigator or sub-investigator determines that the patient is ineligible to participate in the research

Target sample size

30


Research contact person

Name of lead principal investigator

1st name hiroki
Middle name
Last name kawashima

Organization

Nagoya University Hospital

Division name

Department of Endoscopy

Zip code

466-8560

Address

65, Tsuruma-cho, Showa-ku, Nagoya

TEL

0527412111

Email

h-kawa@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Norihiro
Middle name
Last name Imai

Organization

Nagoya University Hospital

Division name

Department of Endoscopy

Zip code

466-8560

Address

65, Tsuruma-cho, Showa-ku, Nagoya

TEL

0527412111

Homepage URL


Email

norihiro@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University

Institute

Department

Personal name



Funding Source

Organization

Nagoya University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee

Address

65, Tsuruma-cho, Showa-ku, Nagoya

Tel

0527412111

Email

ethics@med.nagoya-u.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

2021 Year 04 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

Preinitiation

Date of protocol fixation

2020 Year 12 Month 11 Day

Date of IRB


Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2024 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 12 Month 11 Day

Last modified on

2020 Year 12 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048774


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name