Early diagnosis of pancreatic cancer using duodenal fluid biomarkers

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

This project will see if pancreatic fluid collected during routine endoscopy can help detect early pancreatic cancer in adults.

Quick facts

• Study type: Observational
• Enrollment: 263 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Asan Medical Center (Academic / other)
• Locations: 3 sites (Aurora, Colorado and 2 other locations)
• Trial ID: NCT07030348 on ClinicalTrials.gov

What this trial studies

This prospective observational study collects duodenal pancreatic fluid during clinically indicated upper endoscopy, endoscopic ultrasound, or ERCP from adults with confirmed or suspected pancreatic cancer and from non-pancreatic control patients. Samples will be analyzed for molecular and humoral biomarkers that might distinguish early pancreatic cancer from other pancreatic conditions. The study is being conducted at tertiary centers in the United States and Korea and compares biomarker profiles between cancer and non-cancer groups. The goal is to identify candidate markers that could be validated in larger diagnostic studies.

Who should consider this trial

Good fit: Adults (age 19 or older) undergoing planned upper endoscopy, endoscopic ultrasound, or ERCP with either confirmed or suspected pancreatic ductal adenocarcinoma or with pancreatic cystic disease or pancreatitis are ideal candidates.

Not a fit: People who cannot undergo endoscopy, are under 19 years old, or who live far from participating centers and cannot travel are unlikely to receive direct benefit from participation.

Why it matters

Potential benefit: If successful, this approach could enable earlier detection of pancreatic cancer using a minimally invasive sample taken during standard endoscopic procedures, potentially improving treatment options and survival.

How similar studies have performed: Biomarker work in blood and tissue has shown promise, but using duodenal pancreatic fluid is relatively novel and has limited prior large-scale validation.

Eligibility criteria

Inclusion Criteria:

Among the patients requiring gastro-duodenal endoscopy, endoscopic ultrasound, or ERCP for medical purposes, the pancreatic cancer group should meet the criteria numbered 1, 2, and either 3 or 4.

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.

The non-pancreatic cancer group should meet the criteria numbered 1, 2, and either 3 or 4.

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. Patients with pancreatic cystic tumors or patients with acute or chronic pancreatitis.
4. No evidence of a pancreatic disease.

Exclusion Criteria:

The exclusion criteria for the pancreatic cancer and the 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.

Where this trial is running

Aurora, Colorado and 2 other locations

• University of Colorado Hospital — Aurora, Colorado, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• Asan Medical Center — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: HyeJin Song, CRC

Conditions Pancreatic Cancers; Pancreatic Diseases