Early diagnosis of pancreatic cancer using duodenal fluid biomarkers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: asangicrc@gmail.com
• Phone: +82-2-2045-3825

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.