Early Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancers, Pancreatic Diseases. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Identification of Biomarkers for Early Pancreatic Cancer Detection [Time frame: Up to 1 year from baseline]
Secondary outcome measures (1)
- External Validation Using U.S. Samples [Time frame: Up to 2 year from baseline]
Eligibility criteria
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.
- 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.
The non-pancreatic cancer group should meet the criteria numbered 1, 2, and either 3 or 4.
- 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.
- Patients with pancreatic cystic tumors or patients with acute or chronic pancreatitis.
- No evidence of a pancreatic disease.
Exclusion criteria
The exclusion criteria for the pancreatic cancer and the non-pancreatic cancer groups will be:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 2 centers
- University of Colorado Hospital — Aurora
- Cleveland Clinic — Cleveland
South Korea · 1 center
- Asan Medical Center — Seoul
Identifiers
NCT: NCT07030348 · DHP_Bio · AMC_IRB_2023-1498