Pancreatic Cancers, Pancreatic Diseases
Conditions
Brief 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.
Interventions
None listed
Sponsors
The Cleveland Clinic
University of Colorado, Denver
Do Hyun Park
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of Biomarkers for Early Pancreatic Cancer Detection | Up to 1 year from baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| External Validation Using U.S. Samples | Up to 2 year from baseline | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Optimizing Sample Collection Volume | Up to 6 month from baseline | Correlation between duodenal fluid sample volume (mL) and biomarker detection sensitivity (AUC or concentration) |
| Assessing Racial Differences in Biomarker Expression | Up to 2 year from baseline | Mean biomarker expression levels in Korean vs. U.S. cohorts as measured in duodenal fluid samples |
| Evaluating the Impact of Secretin Administration | Up to 1 year from baseline | Comparison of biomarker concentrations in duodenal fluid with vs. without secretin stimulation |
| Longitudinal Analysis of non-pancreatic cancer group Samples (Asan Medical Center Only) | Up to 2 year from baseline | Change in biomarker levels between first and second duodenal fluid samples in non-pancreatic cancer participants |
Countries
South Korea, United States
Contacts
Primary ContactHyeJin Song, CRC
Outcome results
None listed