UMIN-CTR Clinical Trial

Basic information
Public title	YCU Early Detection Project of Pancreatic cancer led by EUS 2023- Prospective observational study
Acronym	YCU Project 2023
Scientific Title	YCU Early Detection Project of Pancreatic cancer led by EUS 2023- Prospective observational study on improvement 5 year survival rate
Scientific Title:Acronym	YCU Project 2023
Region	Japan

Condition
Condition	Pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To study and establish the strategy in the diagnosis of early pancreatic cancer diameter less than 10mm in diameter through the sessional cooperation system between YCU and primary care units in Yokohama south district's This is 5-year prospective observational research aimed at evaluating the effect of elective EUS for pts with risks.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	5-year survival rate of the pts with pancreatic cancer in YCU hospital
Key secondary outcomes	The rate of early pancreatic cancers/The total number of outpatients with cancer risks

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Pts will have a planned EUS to investigate pancreatic disorders. Risks; 1)pts with abdominal pain or weight loss 2)abnormality of pancreatic enzyme 3)Elevation of tumor marker 4)Dilatation of pancreatic duct more than 2mm in diameter 5)pancreatic cyst 6)diffuse or focal swollen of the pancreas 7)Loacalized atarophy of the pancreas 8)new onset of DM or worsening DM 9)chroninc pancreatitis or autoimmune pancreatitis 10)family history of pancreatic disorders: parenr, child or siblings)
Key exclusion criteria	1)mental disorders who can't judge the medical treatment. 2)pts who was assessed to be inappropriate as candidates by investigators.
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name kensuke Middle name Last name kubota
Organization	Yokohama City University Hospital
Division name	Endoscopic Unit
Zip code	236-0004
Address	Fukuura3-9, Kanazawa, Yokohama
TEL	045-787-2800
Email	kubotak@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name kensuke Middle name Last name kubota
Organization	Yokoham City University Hpsopital
Division name	Endoscopic Unit
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa,Yokohama
TEL	045-787-2800
Homepage URL
Email	kubotak@ykohama-cu.ac.jp

Sponsor
Institute	Endoscopic Unit, Yokohama City University Hospital
Institute
Department

Funding Source
Organization	Yokohama City University
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	Yokohama City University Hospital
Address	3-9 Fukuura, Kanazawa, Yokohama
Tel	045-787-2800
Email	kubotak@yokohama-cu.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	2022 Year 12 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	2022 Year 09 Month 07 Day
Date of IRB	2022 Year 10 Month 27 Day
Anticipated trial start date	2023 Year 01 Month 05 Day
Last follow-up date	2032 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observatory study covered by health insurance of Japan.

Management information
Registered date	2022 Year 11 Month 07 Day
Last modified on	2022 Year 11 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055544