NCT06388967

Pancreatic Cancer Detection Consortium

Early Detection of Pancreatic Cancer: Prospective Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to prospective validate an exosome-based miRNA signature for noninvasive and early detection of pancreatic ductal adenocarcinoma.

Detailed description

Pancreatic ductal adenocarcinoma (PDAC) is one of the deadliest forms of cancer. It often goes undetected until it is at an advanced stage, making it challenging to treat. Currently, only a small percentage of patients are diagnosed early enough for effective treatment. While a blood marker exists, called serum carbohydrate antigen 19-9 (CA19-9), it is used primarily to track the disease, and it is unreliable for early detection. To address this problem, the researchers have developed a new method to analyze circulating vesicles (called exosomes), which contain specific genetic material called microRNAs (miRNAs). In a previous study, by analyzing both the miRNAs that circulate freely in serum and the miRNAs that are inside the exosomes, the researchers have already identified a combination of 13 miRNAs that could accurately detect early-stage PDAC. In this study, the researchers will test this method in a larger international cohort study. This study aims to confirm the effectiveness of this approach in identifying PDAC at its earliest stages.

Conditions

• Pancreatic Cancer
• Pancreatic Carcinoma
• Pancreatic Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms
• Pancreatic Cancer Stage I
• Pancreatic Cancer Stage
• Pancreatic Cancer Resectable
• Pancreatic Cancer Stage 0
• Pancreatic Cancer Stage II
• Pancreatic Cancer Stage III
• Pancreatic Cancer, Adult
• Pancreatic Cancer Non-resectable

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PANcreatic cancer Exosome Early detectiON (PANXEON)	This test will utilize quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) to quantify the expression levels of 5 cell-free and 8 exosome-miRNAs in plasma samples obtained from patients with pancreatic ductal adenocarcinoma and from individuals without it

Timeline

• Start date: 2023-03-15
• Primary completion: 2026-06-18
• Completion: 2026-06-18
• First posted: 2024-04-29
• Last updated: 2025-12-19

Locations

11 sites across 3 countries: United States, Japan, South Korea