UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061922 |
|---|---|
| Receipt number | R000070855 |
| Scientific Title | Discovery of serum proteome biomarkers and integration with pancreatitis-related gene polymorphisms for prediction of post-ERCP pancreatitis |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/15 22:41:20 |
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Basic information
Public title
Discovery of serum proteome biomarkers and integration with pancreatitis-related gene polymorphisms for prediction of post-ERCP pancreatitis
Acronym
Biomarker study for post-ERCP pancreatitis
Scientific Title
Discovery of serum proteome biomarkers and integration with pancreatitis-related gene polymorphisms for prediction of post-ERCP pancreatitis
Scientific Title:Acronym
Biomarker study for post-ERCP pancreatitis
Region
| Japan |
Condition
Condition
post ERCP pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To identify serum proteome biomarkers associated with the development of post-ERCP pancreatitis (PEP) and to obtain foundational knowledge for constructing a PEP prediction model through integrated analysis with pancreatitis-related gene polymorphisms.
Basic objectives2
Others
Basic objectives -Others
Biomarker discovery and disease onset prediction
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of serum proteins significantly altered between PEP and non-PEP groups by STL/LEL lectin enrichment-LC-MS/MS analysis of pre-ERCP (approximately 24 hours before) and post-ERCP (24 hours after) sera (fold change >=2, FDR <=1%)
Key secondary outcomes
1.Association between single nucleotide polymorphisms of pancreatitis-related genes (PRSS1, SPINK1, CTRC, CFTR) and PEP development (assessed within 24 hours after ERCP)
2.Validation of candidate biomarker proteins identified in the Discovery phase by ELISA or selected reaction monitoring (SRM) in an independent validation cohort
3.Predictive accuracy (AUC) of an integrated PEP prediction score combining proteome data and gene polymorphism data
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
Patients aged 20 years or older who are hospitalized at Juntendo University Hospital, Nerima Hospital, or Urayasu Hospital and are scheduled to undergo or have previously undergone ERCP for the diagnosis or treatment of hepatobiliary-pancreatic diseases, and who have provided written informed consent after receiving a thorough explanation of the study
Key exclusion criteria
Patients from whom written informed consent cannot be obtained, or those deemed ineligible by the principal investigator
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Isayama |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
TEL
03-3813-3111
t.takahashi.cp@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
TEL
03-3813-3111
Homepage URL
t.takahashi.cp@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Gastroenterology
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
Juntendo University Faculty of Medicine Research Ethics Committee
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
Tel
03-3813-3111
hongo-rinri@juntendo.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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2027 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2031 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2031 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is a prospective multicenter observational study. Pre- and post-ERCP serum samples are collected from patients undergoing ERCP for the first time. Proteome analysis using STL/LEL lectin enrichment-LC-MS/MS and pancreatitis-related gene polymorphism analysis are performed. Eligible patients are those admitted to participating institutions who are scheduled to undergo ERCP and meet the inclusion criteria.
Management information
Registered date
| 2026 | Year | 06 | Month | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070855
