UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049449 |
|---|---|
| Receipt number | R000055544 |
| Scientific Title | YCU Early Detection Project of Pancreatic cancer led by EUS 2023- Prospective observational study on improvement 5 year survival rate |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2022/11/07 18:19:44 |
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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
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
kubotak@ykohama-cu.ac.jp
Sponsor or person
Institute
Endoscopic Unit, Yokohama City University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055544
