NCT07030348 Early Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study
| NCT ID | NCT07030348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Do Hyun Park |
| Condition | Pancreatic Cancers |
| Study Type | OBSERVATIONAL |
| Enrollment | 263 participants |
| Start Date | 2024-01-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 263 participants in total. It began in 2024-01-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07030348 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Pancreatic Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07030348 currently recruiting?
Yes, NCT07030348 is actively recruiting participants. Contact the research team at asangicrc@gmail.com for enrollment information.
Where is the NCT07030348 trial being conducted?
This trial is being conducted at Aurora, United States, Cleveland, United States, Seoul, South Korea.
Who is sponsoring the NCT07030348 clinical trial?
NCT07030348 is sponsored by Do Hyun Park. The trial plans to enroll 263 participants.
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