Early Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorDo Hyun Park
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients who require a gastro-duodenal endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography (ERCP) for medical purposes will be enrolled in this study. The pancreatic cancer group and the control non-pancreatic cancer group will be recruited.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
263 Participants
are grouped into 2 trial groupsGroup A: Pancreatic Cancer Group (DP)
Group B: Non-Pancreatic Cancer Group (DC)
Trial outcomes
Primary outcomes
1
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 baselineSecondary outcomes
1
External Validation Using U.S. Samples
Area under the ROC curve (AUC) of candidate biomarkers in the U.S. validation cohort using cut-off values derived from the Korean training cohort
Time frame
Up to 2 year from baselineOther outcomes
1
Optimizing Sample Collection Volume
Correlation between duodenal fluid sample volume (mL) and biomarker detection sensitivity (AUC or concentration)
Time frame
Up to 6 month from baseline2
Assessing Racial Differences in Biomarker Expression
Mean biomarker expression levels in Korean vs. U.S. cohorts as measured in duodenal fluid samples
Time frame
Up to 2 year from baseline3
Evaluating the Impact of Secretin Administration
Comparison of biomarker concentrations in duodenal fluid with vs. without secretin stimulation
Time frame
Up to 1 year from baseline4
Longitudinal Analysis of non-pancreatic cancer group Samples (Asan Medical Center Only)
Change in biomarker levels between first and second duodenal fluid samples in non-pancreatic cancer participants
Time frame
Up to 2 year from baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Do Hyun Park
Lead sponsor
Asan Medical Center
Sponsor institution
The Cleveland Clinic
Collaborator
University of Colorado, Denver
Collaborator
Source ClinicalTrials.gov