RecruitingObservational

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

NCT ID: NCT07030348Sponsor: Do Hyun ParkLast updated: 2025-06-22

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.

Detailed description

Pancreatic cancer is the fourth leading cancer-related mortality disease in the United States, with a five-year survival rate of 11%, which is a very poor prognosis, 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, the biomarkers of humoral fluids associated with the early diagnosis of pancreatic cancer are not well understood. Duodenal pancreatic fluids can be easily obtained through an endoscopy and contain a large amount of pancreatic fluid secreted by the pancreas, which is known to be a candidate of biomarkers for early diagnosis of pancreatic cancer. However, there have been few studies using duodenal fluids in Korea. This study aims to prospectively analyze biomarkers for early diagnosis of pancreatic cancer using duodenal fluids obtained by endoscopy in pancreatic and non-pancreatic cancer groups.

Arms & interventions

Outcome measures

Primary

Identification of Biomarkers for Early Pancreatic Cancer Detection
Area Under the Receiver Operating Characteristic Curve (AUC) and 95% Confidence Interval (CI) of candidate biomarkers in the training cohort. If the AUC falls within ±5% of the target value (0.94), the optimal cutoff value for pancreatic cancer differentiation will be reported using Youden's Index.
Time frame: Up to 1 year from baseline

Secondary

External Validation Using U.S. Samples
Time frame: Up to 2 year from baseline

Eligibility criteria

Sex: AllAge: 19 Years and olderHealthy volunteers: Yes

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.

Study locations (2)

University of Colorado Hospital

Aurora, Colorado, 80045

Recruiting

Cleveland Clinic

Cleveland, Ohio, 44195

Recruiting