Clinical trial · Observational
Early Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancers | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Diseases | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Pancreatic Cancer Group (DP)
- description
- 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.
- label
- Non-Pancreatic Cancer Group (DC)
- description
- Participants with pancreatic cystic tumors or with acute or chronic pancreatitis, or with no evidence of a pancreatic disease
Primary outcomes (1)
- measure
- Identification of Biomarkers for Early Pancreatic Cancer Detection
- timeFrame
- Up to 1 year from baseline
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available