UMIN-CTR Clinical Trial

Basic information
Public title	Metabolomics of EUS-FNA specimens of pancreaticobiliary lesions
Acronym	Metabolomics of EUS-FNA specimens
Scientific Title	Metabolomics of EUS-FNA specimens of pancreaticobiliary lesions
Scientific Title:Acronym	Metabolomics of EUS-FNA specimens
Region	Japan

Condition
Condition	pancreaticobiliary lesions
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the predictors for the disease prognosis and treatment effect by metabolomics of EUS-FNA specimens
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between metabolomes of EUS-FNA specimens and overall survival
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	Patients judged by the physician in charge to be inappropriate as research subjects
Target sample size	100

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
Email	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
Email	mkuwatan@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University
Institute
Department

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
Email	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	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	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	Prediction of clinical course and prognosis based on metabolomics

Management information
Registered date	2021 Year 10 Month 05 Day
Last modified on	2021 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052138