UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046880 |
|---|---|
| Receipt number | R000053487 |
| Scientific Title | Koasato university Pancreatic cancer Screening Project |
| Date of disclosure of the study information | 2022/02/10 |
| Last modified on | 2022/03/15 07:55:07 |
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Basic information
Public title
Koasato university Pancreatic cancer Screening Project
Acronym
Koasato university Pancreatic cancer Screening Project
Scientific Title
Koasato university Pancreatic cancer Screening Project
Scientific Title:Acronym
Koasato university Pancreatic cancer Screening Project
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To diagnose pancreatic cancer at an earlier stage by screening and conducting regular surveillance of individuals with risk factors for the pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
number, incidence, and stage of pancreatic cancer cases detected by each risk factor
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
Patients =or >20 years of age, and providing informed consent. Eligibility is determined when one or more of the following criteria are met.
1. patients with symptoms suspicious for pancreatic cancer.
2. patients with tumor marker-positive
3. patients with abnormalities of serum pancreatic enzyme
4. patients with dilated main pancreatic duct
5. patients with pancreatic cysts
6. patients with new onset type 2 diabetes
7. diabetic patients with poor control
8. patients with chronic pancreatitis
9. patients with family history of pancreatic cancer
10. hereditary pancreatitis
11. patients with a history of breast and/or ovarian cancer
12. Puetz-Jegahers syndrome
13. Familial atypical multiple mole melanoma syndrome
14. Lynch syndrome
15. Familial adenomatous polyposis syndrome
Key exclusion criteria
patients whose participation in the trial was judged to be inappropriate by the investigator
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Tomohisa |
| Middle name | |
| Last name | Iwai |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa
TEL
+81247788111
t-iwai@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Okuwaki |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa
TEL
+81247788111
Homepage URL
kokuwaki@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Institutional Ethics Committee of Kitasato University Hospital
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa
Tel
+81427787756
rinri@med.kitasato-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
JCHO相模野病院 (JCHO Sagamino Hospital)
伊勢原協同病院 (Isehara Kyodo Hospital)
相模原協同病院 (Sagamihara Kyodo Hospital)
平塚共済病院 (Hiratsuka Kyosai Hospital)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 10 | 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 | 03 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 25 | 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
screening and conducting regular surveillance of individuals with risk factors for the pancreatic cancer
Management information
Registered date
| 2022 | Year | 02 | Month | 10 | Day |
Last modified on
| 2022 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053487
