UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045675 |
|---|---|
| Receipt number | R000052121 |
| Scientific Title | Metabolomics of pancreatic juice, bile, and duodenal juice in patients with pancreatobiliary disease |
| Date of disclosure of the study information | 2021/10/18 |
| Last modified on | 2024/04/07 09:23:24 |
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Basic information
Public title
Metabolomics of pancreatic juice, bile, and duodenal juice in patients with pancreatobiliary disease
Acronym
Metabolomics of pancreatic juice, bile, and duodenal juice
Scientific Title
Metabolomics of pancreatic juice, bile, and duodenal juice in patients with pancreatobiliary disease
Scientific Title:Acronym
Metabolomics of pancreatic juice, bile, and duodenal juice
Region
| Japan |
Condition
Condition
pancreatobiliary disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the differences of metabolomes in pancreatic juice/bile between malignant and benign pancreatobiliary diseases
Basic objectives2
Others
Basic objectives -Others
Differentiation of malignant or benign pancreatobiliary diseases
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The differences of metabolomes in pancreatic juice/bile between malignant and benign pancreatobiliary diseases
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients with suspected pancreaticobiliary lesion by blood or imaging tests
(2)Patients who require EUS/ERCP/EUS-FNA
(3)Patients who have given written informed consent for study recruitment
Key exclusion criteria
(1)Patients who cannot undergo peroral endoscopic examination
(2)Patients judged by the physician in charge to be inappropriate as research subjects
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8648
Address
North 14, West 5, Kita-ku, Sapporo
TEL
011-176-1161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8648
Address
North 14, West 5, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
mkuwatan@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido Univerisy
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
North 14, West 5, Kita-ku, Sapporo
Tel
011-716-1161
crjimu@huhp.hokuda.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 | 10 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2021 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Accuracy, clinical course, and prognosis based on metabolomics
Management information
Registered date
| 2021 | Year | 10 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052121
