RecruitingNCT07030348

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

Sponsor

Do Hyun Park

Enrollment

263 participants

Start Date

Jan 2, 2024

Study Type

OBSERVATIONAL

Conditions

Pancreatic Diseases Pancreatic Cancers

Summary

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.

Eligibility

Min Age: 19 Years

Inclusion Criteria10

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 Criteria4

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.