UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056746 |
|---|---|
| Receipt number | R000064851 |
| Scientific Title | Development of early diagnosis method for pancreatic cancer using extracellular vesicles derived from pancreatic juice, duodenal fluid, and plasma. |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/01/17 17:31:42 |
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Basic information
Public title
Development of early diagnosis method for pancreatic cancer using extracellular vesicles derived from pancreatic juice, duodenal fluid, and plasma.
Acronym
Development of early diagnosis method for pancreatic cancer using extracellular vesicles derived from pancreatic juice, duodenal fluid, and plasma.
Scientific Title
Development of early diagnosis method for pancreatic cancer using extracellular vesicles derived from pancreatic juice, duodenal fluid, and plasma.
Scientific Title:Acronym
Development of early diagnosis method for pancreatic cancer using extracellular vesicles derived from pancreatic juice, duodenal fluid, and plasma.
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We aim to develop a screening test for early pancreatic cancer by analyzing proteins (S100P protein: S100 calcium binding protein P) and miRNAs in extracellular vesicles (EVs) derived from pancreatic juice, duodenal fluid, and blood collected during endoscopic retrograde cholangiopancreatography (ERCP).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We aim to develop a new method for early diagnosis of pancreatic cancer by analyzing the expression of S100P protein and miRNA in extracellular vesicles derived from blood, pancreatic juice, and duodenal fluid collected from patients with pancreatic cancer and benign disease. We will create ROC curves and calculate AUC for S100P protein concentration and expression of miRNA to evaluate diagnostic ability. Cut-off values will be calculated using the Youden index. Sensitivity and specificity will be calculated based on the obtained cut-off values, and compared with the diagnostic ability of pancreatic juice cytology.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Duodenal fluid is collected using a catheter during ERCP.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[Cases of pancreatic ductal carcinoma or suspected pancreatic ductal carcinoma]
1: The age at the time of consent is 18 years or older.
2: Patients with pancreatic ductal carcinoma or suspected pancreatic ductal carcinoma who are expected to undergo surgery and are scheduled to undergo ERCP for preoperative testing (excluding obvious stage IV pancreatic cancer).
3: The patient is given an explanation using an explanatory document, and written consent is obtained from the patient.
[Cases of benign pancreatic disease(chornic pancreatitis) or common bile duct stones(normal pancreas)]
-Cases of chronic pancreatitis-
1: The age at the time of consent is 18 years or older.
2: Prior imaging tests have confirmed that there are no findings suggestive of malignant pancreatic disease.
3: ERCP is scheduled for investigation of chronic pancreatitis
4: The patient is given an explanation using an explanatory document, and written consent is obtained from the patient.
*However, if a patient is diagnosed with a malignant disease through cytology, the patient will not be included in this study.
-Cases of common bile duct stones-
1: The age at the time of consent is 18 years or older.
2: Prior imaging tests have confirmed that there are no findings suggestive of pancreatic tumors or pancreatic diseases.
3: ERCP is scheduled for common bile duct stones.
4: The patient is given an explanation using an explanatory document, and written consent is obtained from the patient.
Key exclusion criteria
If any of the following applies to the patient, this patient will be excluded.
1: Those who have a history of malignant disease in the upper gastrointestinal tract (esophageal cancer, gastric cancer, duodenal papilla tumor, etc.)
2: Those who have a history of upper gastrointestinal surgery (gastrectomy, pancreaticoduodenectomy, upper gastrointestinal reconstruction, etc.)
3: There is obvious bile duct malignancy.
4: Those who have received preoperative chemotherapy for pancreatic ductal carcinoma at the time of registration or in the past.
5: Those who have a history of allergies to drugs used during endoscopic examinations.
6: Those who are judged by the attending physician to be ineligible for this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Nakamura |
Organization
Kyushu university faculty of medical sciences
Division name
Department of surgery and oncology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
0926425441
araki.tomoyuki.981@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Araki |
Organization
Kyushu university faculty of medical sciences
Division name
Department of surgery and oncology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
0926425444
Homepage URL
araki.tomoyuki.981@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu university
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Boards / Ethics Committees of Kyushu University
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel
0926426254
byskenkyu@jimu.kyushu-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
| 2025 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 17 | Day |
Last modified on
| 2025 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064851
