UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057488 |
|---|---|
| Receipt number | R000065690 |
| Scientific Title | Accurate imaging diagnosis of early pancreatic cancer using combined indirect imaging findings |
| Date of disclosure of the study information | 2025/04/02 |
| Last modified on | 2025/04/02 13:35:33 |
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Basic information
Public title
Accurate imaging diagnosis of early pancreatic cancer using combined indirect imaging findings
Acronym
Accurate imaging diagnosis of early pancreatic cancer using combined indirect imaging findings
Scientific Title
Accurate imaging diagnosis of early pancreatic cancer using combined indirect imaging findings
Scientific Title:Acronym
Accurate imaging diagnosis of early pancreatic cancer using combined indirect imaging findings
Region
| Japan |
Condition
Condition
early pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the combination of indirect imaging findings improves the diagnostic performance for early pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was to evaluate the diagnostic performance of characteristic indirect imaging findings, with a particular focus on the diagnostic value of combined indirect imaging findings of malignant lesions.
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Between May 2015 and February 2024, ERP examinations performed to diagnose suspected EPC based on irregular MPD calibers.
Key exclusion criteria
Patients were excluded if they had a follow-up period of < 5 years without surgical resection, were lost to follow-up, lacked imaging data (CT/MRI/ERP), had multiple stenoses due to chronic pancreatitis, or had histologically confirmed PC with a diameter > 10 mm. In addition, PC originating from branch duct intraductal papillary mucinous neoplasms was naturally excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Faculty of Medicine, Oita University
Division name
Department of Gastroenterology/Department of Advanced Gastrointestinal Cancer Medicine
Zip code
8795593
Address
1-1 Idaigaoka, hasama-cho, Yufu, Oita, 8795593, Japan
TEL
+81-97-549-4411
sagami1985@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Sagami |
Organization
Faculty of Medicine, Oita University
Division name
Department of Gastroenterology/Department of Advanced Gastrointestinal Cancer Medicine
Zip code
8795593
Address
1-1 Idaigaoka, hasama-cho, Yufu, Oita, 8795593, Japan
TEL
+81-97-549-4411
Homepage URL
sagami1985@yahoo.co.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
None
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
Faculty of Medicine, Oita University
Address
1-1 Idaigaoka, hasama-cho, Yufu, Oita, 8795593, Japan
Tel
+81-97-549-4411
sagami1985@yahoo.co.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
| 2025 | Year | 04 | Month | 02 | 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
| 2024 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2029 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 04 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065690
