Actively Recruiting
Early Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study
Led by Do Hyun Park · Updated on 2025-06-22
263
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Do Hyun Park
Lead Sponsor
T
The Cleveland Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pancreatic cancer is a leading cause of cancer-related deaths in the United States, with a low five-year survival rate of 11%. Only a small portion of patients are eligible for surgery due to the disease stage. This research aims to improve early diagnosis by identifying biomarkers in duodenal pancreatic fluid, which is easier to collect during an endoscopy, addressing the unmet need for better early detection methods. The study involves two groups: one with confirmed or suspected pancreatic ductal adenocarcinoma (PDAC) and another with pancreatic cystic tumors, pancreatitis, or no pancreatic disease. Duodenal fluid samples will be collected during medically necessary endoscopic procedures such as upper endoscopy, endoscopic ultrasound, or ERCP. Researchers will analyze these samples to discover biomarkers linked to early pancreatic cancer. Participants will undergo endoscopy-related procedures as part of their medical care, during which duodenal fluid will be collected for analysis. The primary outcome focuses on identifying biomarkers within one year from the baseline, with a secondary goal of validating findings using samples from the U.S. Participants are monitored for up to two years, and data collected will help understand early signs of pancreatic cancer for potential future diagnostic use.
CONDITIONS
Brief Title
Early Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 19 years old
- Have completed informed consent for planned upper endoscopy, endoscopic ultrasound, or ERCP before duodenal fluid collection
- For pancreatic cancer group: biopsy-proven stage I-IV pancreatic ductal adenocarcinoma or suspected pancreatic cancer on imaging with scheduled endoscopic ultrasound-guided pancreatic biopsy
- For non-pancreatic cancer group: pancreatic cystic tumors, acute or chronic pancreatitis, or no evidence of pancreatic disease
You will not qualify if you...
- Anatomical conditions preventing direct sampling of duodenal fluid
- Hemodynamically unstable and unable to undergo endoscopy
- Uncontrolled large amount of ascites preventing endoscopy
- Coagulation disorders that cannot be corrected and prevent endoscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo endoscopy procedures to collect duodenal fluids for biomarker analysis related to early diagnosis of pancreatic cancer.
1 visit (in-person)
Duration - Up to 2 years
Participants are observed for up to 2 years to validate biomarkers and monitor health outcomes related to pancreatic cancer diagnosis.
Periodic visits depending on follow-up schedule
Trial Site Locations
Total: 3 locations
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
3
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
Research Team
H
HyeJin Song, CRC
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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