UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062830 |
|---|---|
| Receipt number | R000071922 |
| Scientific Title | Elucidating mechanisms of hostmicrobiome interaction in cholangiocarcinoma development |
| Date of disclosure of the study information | 2026/09/05 |
| Last modified on | 2026/09/05 12:02:12 |
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Basic information
Public title
Elucidating mechanisms of hostmicrobiome interaction in cholangiocarcinoma development
Acronym
Elucidating mechanisms of hostmicrobiome interaction in cholangiocarcinoma development
Scientific Title
Elucidating mechanisms of hostmicrobiome interaction in cholangiocarcinoma development
Scientific Title:Acronym
Elucidating mechanisms of hostmicrobiome interaction in cholangiocarcinoma development
Region
| Japan | Europe |
Condition
Condition
biliary tract disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
WP1 Identification of a CCA-Associated Microbiome Signature
This aim is to comprehensively identify characteristic alterations across the microbiome, metabolome, and host genome in patients with cholangiocarcinoma (CCA).
WP2 Functional Analysis of Candidate Bacteria using "Cholangiocyte organoid model"
This aim will validate the pathogenic potential of candidate bacteria identified in WP1 by assessing their direct impact on cholangiocytes in a sophisticated in vitro model.
Basic objectives2
Others
Basic objectives -Others
WP2 Functional Characterization of Candidate Bacteria in Advanced In Vitro Models:
Patient derived cholangiocyte organoids integrated into microfluidic devices, candidate bacteria will be functionally tested for their ability to induce epithelial dysfunction, inflammatory signaling, and oncogenic pathways. This two year project provides crucial mechanistic insights linking the biliary microbiome and CCA pathogenesis, establishing the foundation for future in vivo validation and microbiome based diagnostic and therapeutic strategies.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Initiate multiomics analysis (WP1). Establish cholangiocyte organoid models and optimize coculture systems (WP2). Identify top candidate bacteria and prepare functional validation studies. Complete functional characterization of candidate pathobionts (WP2). Integrate data across both work packages, prepare manuscripts for publication in high impact journals.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals aged 20 or older who are clinically suspected of having biliary tract cancer, present with a malignant stricture in any part of the biliary tract and suspected impaired bile outflow, and are undergoing ERCP.
Individuals aged 20 or older undergoing ERCP for impaired bile outflow due to common bile duct stones, or for biliary strictures associated with benign biliary stricture, chronic pancreatitis, or liver disease.
Key exclusion criteria
Individuals meeting the diagnostic criteria for cholangitis (Tokyo Guidelines 2018) [6].
Individuals with a history of sphincterotomy or biliary stent placement.
Individuals who received antibiotics within the one month prior to the ERCP procedure.
Individuals who received anticancer drugs within the one month prior to the ERCP procedure.
Individuals otherwise deemed unsuitable for study participation by the principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | ICHITARO |
| Middle name | |
| Last name | HORIUCHI |
Organization
Shinshu university
Division name
Gastroenterology
Zip code
390-8621
Address
Asahi3-1-1 Matsumoto Nagano
TEL
09069425947
ichita0617@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | ICHITARO |
| Middle name | |
| Last name | HORIUCHI |
Organization
Shinshu university
Division name
Gastroenterology
Zip code
390-8621
Address
Asahi3-1-1 Matsumoto Nagano
TEL
09069425947
Homepage URL
ichita0617@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university
Institute
Department
Personal name
Funding Source
Organization
Technische Universitat Dresden
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Germany
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu university
Address
Asahi3-1-1 Matsumoto Nagano
Tel
09069425947
ichita0617@shinshu-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
信州大学医学部附属病院（長野県）、長野赤十字病院（長野県）、長野市民病院（長野県）、篠ノ井総合病院（長野県）、北アルプス医療センター（長野県）、安曇野赤十字病院（長野県）、諏訪赤十字病院（長野県）、松本市立病院（長野県）、松本医療センター（長野県）、昭和伊南総合病院（長野県）、県立木曽病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 05 | 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
| 2026 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient enrollment in progress
Management information
Registered date
| 2026 | Year | 09 | Month | 05 | Day |
Last modified on
| 2026 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071922
