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Development of early diagnosis method for pancreatic cancer using extracellular vesicles derived from pancreatic juice, duodenal fluid, and plasma.

Development of early diagnosis method for pancreatic cancer using extracellular vesicles derived from pancreatic juice, duodenal fluid, and plasma. - Development of early diagnosis method for pancreatic cancer using extracellular vesicles derived from pancreatic juice, duodenal fluid, and plasma.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056746
Enrollment
50
Registered
2025-03-01
Start date
2025-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer

Interventions

Duodenal fluid is collected using a catheter during ERCP.

Sponsors

Kyushu university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactTomoyuki Araki

Kyushu university faculty of medical sciences Department of surgery and oncology

araki.tomoyuki.981@m.kyushu-u.ac.jp0926425444

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026