UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041624 |
|---|---|
| Receipt number | R000047517 |
| Scientific Title | Prospective observational study on Improvement of prognosis of Pancreatic Cancer: Early Detection Project of Pancreatic Cancer in Tsu |
| Date of disclosure of the study information | 2020/08/31 |
| Last modified on | 2023/09/03 14:14:15 |
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Basic information
Public title
Prospective observational study on Improvement of prognosis of Pancreatic Cancer:
Early Detection Project of Pancreatic Cancer in Tsu
Acronym
PIPED-Tsu
Scientific Title
Prospective observational study on Improvement of prognosis of Pancreatic Cancer:
Early Detection Project of Pancreatic Cancer in Tsu
Scientific Title:Acronym
PIPED-Tsu
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish a system to efficiently pick up patients with risk factors for pancreatic cancer and to detect them at an early stage through regional medical cooperation between core hospital including Mie University Hospital and the primary care clinics in Tsu area. We will examine the number of pancreatic cancer cases (especially the number of Stage 0/I cases diagnosed) and resection cases that can be diagnosed by this method. We also evaluate the transition of the resection rate and the diagnosis rate of Stage 0/I cases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the rate of patients diagnosed with pancreatic cancer, calculated with a 95% confidence interval. The diagnosis rate is the number of patients diagnosed/total number of study participants.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults aged 20 years or older having 2 or more points on a scoring metric for prespecified pancreatic cancer risk factors will be eligible for referral.
Prespecified risk factors and associated point scores are as follows:
1. symptoms (abdominal pain, jaundice, back pain, or weight loss): 1 point
2. newly diagnosed diabetes mellitus (type 2) or worsening of diabetes: 1 point
3. family history of PC (parent, child, or siblings, including other types of pancreatic neoplasms): 1 point
4. abnormal serum amylase level (high or low): 1 point
5. elevated serum CA19-9 level: 1 point
6. pancreatic duct dilation (>3 mm) or pancreatic cyst detected by echography test: 2 points.
Key exclusion criteria
1) Patients who cannot understand the necessity of detailed examination and follow-up due to cognitive decline etc.
2) Patients who the investigator/co-investigator determined to be inappropriate for inclusion in the study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Yamada |
Organization
Mie University Hospital
Division name
Gastroenterology and Hepatology
Zip code
514-8507
Address
2-174, Edobashi, Tsu-city, Mie-prefecture
TEL
059-232-1111
reiko-t@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Yamada |
Organization
Mie University Hospital
Division name
Gastroenterology and Hepatology
Zip code
514-8507
Address
2-174, Edobashi, Tsu-city, Mie-prefecture
TEL
059-232-1111
Homepage URL
reiko-t@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Mie 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
Mie University Hospital
Address
2-174, Edobashi, Tsu-city, Mie-prefecture
Tel
059-232-1111
reiko-t@clin.medic.mie-u.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
| 2020 | Year | 08 | Month | 31 | 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
| 2020 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Adults aged 20 years or older having 2 or more points on a scoring metric for prespecified pancreatic cancer risk factors will be eligible for referral. If treatment is needed, start treatment such as resection. If there is some kind of lesion but follow-up is possible, follow-up observation by images and blood sampling will be continued every 6 months to 1 year at an institutional hospital in Tsu City.
Management information
Registered date
| 2020 | Year | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047517
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
