Early Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study
NCT ID: NCT07030348
Last Updated: 2025-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
263 participants
OBSERVATIONAL
2024-01-02
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Non-Pancreatic Cancer Group (DC)
Participants with pancreatic cystic tumors or with acute or chronic pancreatitis, or with no evidence of a pancreatic disease
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
19 Years
ALL
Yes
Sponsors
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The Cleveland Clinic
OTHER
University of Colorado, Denver
OTHER
Do Hyun Park
OTHER
Responsible Party
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Do Hyun Park
Professor
Locations
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University of Colorado Hospital
Aurora, Colorado, United States
Cleveland Clinic
Cleveland, Ohio, United States
Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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AMC_IRB_2023-1498
Identifier Type: OTHER
Identifier Source: secondary_id
DHP_Bio
Identifier Type: -
Identifier Source: org_study_id
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