Early Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study
Recruiting · NCT07030348 · Observational (researchers observe without assigning treatment) · Lead sponsor: Do Hyun Park
View the official record on ClinicalTrials.gov →What this trial is about
Purpose Pancreatic cancer is the fourth leading cancer-related mortality disease in the United States, with a five-year survival rate of 11%, and only 10 15% of all pancreatic cancer patients are operable or borderline operable. Therefore, there is an unmet need for early diagnosis of pancreatic cancer; however, biomarkers related to this are not well understood. This study aims to identify biomarkers for the early diagnosis of pancreatic cancer through duodenal pancreatic juice, which can be easily obtained through an endoscopy.
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
- Be at least 19 years old.
- Have completed the informed consent for planned upper endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography before the duodenal fluid collection.
- A biopsy with proven stage I-IV pancreatic ductal adenocarcinoma (PDAC).
- 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.
- Be at least 19 years old.
- Have completed the informed consent for planned upper endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography before the duodenal fluid collection.
- Patients with pancreatic cystic tumors or patients with acute or chronic pancreatitis.
- No evidence of a pancreatic disease.
Exclusion criteria
- The exclusion criteria for the pancreatic cancer and the non-pancreatic cancer groups will be:
- Innate or post-surgical anatomy that precludes direct sampling of duodenal fluid.
- Hemodynamically unstable and unable to have an endoscopy performed.
- A large amount of ascites fluid that is not controlled and unable to have an endoscopy performed.
- A coagulation disorder that cannot be corrected and unable to have an endoscopy performed.
Where it is running
3 locations listed across 2 US states.
- University of Colorado Hospital - Aurora, Colorado, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Asan Medical Center - Seoul, South Korea