Early Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: t
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⁃ 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.

Locations
United States
Colorado
University of Colorado Hospital
RECRUITING
Aurora
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Other Locations
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Contact Information
Primary
HyeJin Song, CRC
asangicrc@gmail.com
+82-2-2045-3825
Time Frame
Start Date: 2024-01-02
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 263
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Do Hyun Park
Collaborators: The Cleveland Clinic, University of Colorado, Denver

This content was sourced from clinicaltrials.gov