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NCT07030348Recruiting

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

Source: ClinicalTrials.gov · Last updated 22 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
263 (estimated)
First submitted
21 May 2025
Start date
2 Jan 2024
Primary completion date
31 Dec 2026
Lead sponsor
Do Hyun Park
NCT number
NCT07030348

What you commit to

  • Study type: Observational
  • Planned participants: 263
  • From 2 Jan 2024 to the primary completion date, 31 Dec 2026
  • 3 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Innate or post-surgical anatomy that precludes direct sampling of duodenal fluid.

Other illness

  • The exclusion criteria for the pancreatic cancer and the non-pancreatic cancer groups will be:
  • A coagulation disorder that cannot be corrected and unable to have an endoscopy performed.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
University of Colorado Hospital
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.