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| ID | Type | Description | Link |
|---|---|---|---|
| AMC_IRB_2023-1498 | Other Identifier | Asan Medical Center Institutional Review Board |
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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
| University of Colorado, Denver | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatic Cancer Group (DP) | Participants with a biopsy with proven stage I-IV pancreatic ductal adenocarcinoma (PDAC), or with suspected pancreatic cancer on imaging and scheduled for an endoscopic ultrasound-guided pancreatic biopsy. | ||
| Non-Pancreatic Cancer Group (DC) | Participants with pancreatic cystic tumors or with acute or chronic pancreatitis, or with no evidence of a pancreatic disease |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 year from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 2 year from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Optimizing Sample Collection Volume | Correlation between duodenal fluid sample volume (mL) and biomarker detection sensitivity (AUC or concentration) | Up to 6 month from baseline |
| Assessing Racial Differences in Biomarker Expression |
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.
The non-pancreatic cancer group should meet the criteria numbered 1, 2, and either 3 or 4.
Exclusion Criteria:
The exclusion criteria for the pancreatic cancer and the non-pancreatic cancer groups will be:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HyeJin Song, CRC | Contact | +82-2-2045-3825 | asangicrc@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Recruiting | Aurora | Colorado | 80045 | United States | |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010182 | Pancreatic Diseases |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Mean biomarker expression levels in Korean vs. U.S. cohorts as measured in duodenal fluid samples
| Up to 2 year from baseline |
| Evaluating the Impact of Secretin Administration | Comparison of biomarker concentrations in duodenal fluid with vs. without secretin stimulation | Up to 1 year from baseline |
| 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 | Up to 2 year from baseline |
| Cleveland Clinic |
| Recruiting |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| D004066 |
| Digestive System Diseases |
| D004700 | Endocrine System Diseases |