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Duodenal Fluid-Based Biomarker study

Early Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009675
Enrollment
131
Registered
2024-08-02
Start date
2024-01-02
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

None listed

Interventions

None listed

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Among the patients requiring gastro-duodenal endoscopy, endoscopic ultrasound, or endoscopic retrograde biliary pancreatic angiography for medical purposes, the pancreatic cancer group should meet the criteria numbered 1, 2, and either 3 or 4. The control non-pancreatic cancer group should meet the criteria numbered 1, 2, and either 5 or 6. 1. Be at least 19 years old 2. Have completed the informed consent for planned upper endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography before the duodenal fluid collection. 3. A biopsy with proven stage I-IV pancreatic ductal adenocarcinoma (PDAC). 4. Suspected pancreatic cancer on imaging and scheduled for an endoscopic ultrasound-guided pancreatic biopsy. 5. Patient with pancreatic cystic tumors or patients with acute or chronic pancreatitis 6. No evidence of a pancreatic disease

Exclusion criteria

Exclusion criteria: The exclusion criteria for the pancreatic cancer and the control non-pancreatic cancer groups will be: 1. Innate or post-surgical anatomy that precludes direct sampling of duodenal fluid. 2. Hemodynamically unstable and unable to have an endoscopy performed. 3. A large amount of ascites fluid that is not controlled and unable to have an endoscopy performed. 4. A coagulation disorder that cannot be corrected and unable to have an endoscopy performed.

Design outcomes

Primary

MeasureTime frame
1. Primary Objective: Adequacy of the amount of duodenal fluid collected (approximately 1.5 mL);2. Secondary objective: Qualitative assessment of the exosomes form the collected duodenal fluids (microRNA)

Countries

Korea, Republic of

Contacts

Public ContactEUN HA KIM

Asan Medical Center

sp98rn@naver.com+82-2-2045-3825

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026