UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052589 |
|---|---|
| Receipt number | R000060012 |
| Scientific Title | Elucidation of the pathogenesis and new diagnostic or therapeutic methods for biliary tract diseases through bile juice analysis. |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/10/23 22:44:36 |
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Basic information
Public title
Elucidation of the pathogenesis and new diagnostic or therapeutic methods for biliary tract diseases through bile juice analysis.
Acronym
Elucidation of the pathogenesis and new diagnostic or therapeutic methods for biliary tract diseases through bile juice analysis.
Scientific Title
Elucidation of the pathogenesis and new diagnostic or therapeutic methods for biliary tract diseases through bile juice analysis.
Scientific Title:Acronym
Elucidation of the pathogenesis and new diagnostic or therapeutic methods for biliary tract diseases through bile juice analysis.
Region
| Japan |
Condition
Condition
Bile duct cancer, primary sclerosing cholangitis, IgG4-related sclerosing cholangitis, secondary sclerosing cholangitis, bile duct stones, cholangitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
In this study, we will analyze the obtained bile juice from various aspects such as genes and bacterial flora, and further examine the relationship with the bicarbonate maintenance mechanism of the biliary epithelium to gain findings that will lead to the development and progression mechanisms of biliary diseases.
Basic objectives2
Others
Basic objectives -Others
Regarding cholelithiasis and cholangitis, identification of factors involved in stone formation and bacterial growth will provide insight into prevention of recurrence.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of DNA, RNA, and exosomes in bile to identify markers that reflect the diagnosis of benign or malignant biliary disease and its prognosis.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults 18 years and older who undergo endoscopic retrograde cholangiopancreatography (ERCP) for biliary tract disease at Nagoya University Hospital.
Key exclusion criteria
Patients considered ineligible for participation in this study by the principal investigator or research assistant.
Cases in which ERCP is difficult to perform or ENBD tube placement is difficult
Patients who have undergone biliary tract surgery
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kawashima |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8560
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL
0527412111
ytakada@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Takada |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
4668560
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi Japan
TEL
0527412111
Homepage URL
ytakada@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethics Committee
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi Japan
Tel
0527412602
ytakada@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
| 2024 | Year | 01 | 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
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For DNA in bile, genes that are frequently mutated in cholangiocarcinoma will be amplified by CR and compared with blood DNA to detect bile-specific mutated DNA. For patients who have undergone surgery, the origin of the mutant DNA will be verified by comparing it with a postoperative pathology specimen. Exosomes will be extracted and analyzed for micro RNA and proteins contained in the exosomes, and their relationship to the pathology will be examined.
For biliary biopsy specimens, channel expression involved in bicarbonate secretion will be confirmed by immunostaining, and the relationship between the expression site and amount and the pathology will be examined. The same staining will be performed on postoperative pathology specimens. For glycans, mass analysis and structural analysis will be performed by glycoproteome analysis to obtain knowledge that will lead to the elucidation of their functions.
For intestinal bacteria, we will collect gastrointestinal mucosa, saliva, stool samples, and bile, compare the species and diversity of bacteria in the samples, and if specific bacteria are identified, we will measure the amount of bacteria by quantitative PCR. In situ hybridization probes specific to the identified bacteria are created to confirm the presence of that species in the tissue.
For organoids, morphological observation using fluorescence microscopy and analysis of expressed genes using qPCR and RNA sequencing will be performed. Reactivity to bacteria, inflammatory cytokines, etc. will be examined to gain insight into the mechanism of transformation from benign to malignant and the mechanisms involved in cancer progression. Attempt to identify pH-dependent markers by changing the ambient pH and capturing changes in expressed genes.
Management information
Registered date
| 2023 | Year | 10 | Month | 23 | Day |
Last modified on
| 2023 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060012
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