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

NCT07030348 | Recruiting

• 2 other identifiers: DHP_BioAMC_IRB_2023-1498
• Study Type: observational
• Target: 263
• Locations: 2 countries
• Sites: 3

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.

Conditions

Pancreatic Cancers; Pancreatic Diseases

Outcome Measures

Primary Outcomes (1)

• Identification of Biomarkers for Early Pancreatic Cancer Detection

  Area Under the Receiver Operating Characteristic Curve (AUC) and 95% Confidence Interval (CI) of candidate biomarkers in the training cohort. If the AUC falls within ±5% of the target value (0.94), the optimal cutoff value for pancreatic cancer differentiation will be reported using Youden's Index.

  Up to 1 year from baseline

Secondary Outcomes (1)

• External Validation Using U.S. Samples

  Up to 2 year from baseline

Other Outcomes (4)

• Optimizing Sample Collection Volume

  Up to 6 month from baseline

• Assessing Racial Differences in Biomarker Expression

  Up to 2 year from baseline

• Evaluating the Impact of Secretin Administration

  Up to 1 year from baseline

Study Arms (2)

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who require a gastro-duodenal endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography (ERCP) for medical purposes will be enrolled in this study. The pancreatic cancer group and the control non-pancreatic cancer group will be recruited.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Do Hyun Park: lead
• The Cleveland Clinic: collaborator
• University of Colorado, Denver: collaborator

Study Sites (3)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

263

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Endocrine System Diseases

Central Study Contacts

HyeJin Song, CRC

CONTACT

+82-2-2045-3825; asangicrc@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 22, 2025
• Study Start: January 2, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1); US (2)