Recruiting

Biomarkers Identification

Sponsor:

Do Hyun Park

Code:

NCT07030348

Conditions

Pancreatic Cancers

Pancreatic Diseases

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT07030348

Start date

Jan 2, 2024

Status verified date

Jun, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

263 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Identification of Biomarkers for Early Pancreatic Cancer Detection [ Time Frame: Up to 1 year from baseline ]

Central Contacts and Locations

Central contacts

Locations

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

More Information

Sponsor

Do Hyun Park

Last update posted

Jun 22, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Do Hyun Park on 2025-06-22.