Pancreatic Cancer Detection Consortium

Recruiting

• Conditions: Pancreatic Cancer; Pancreatic Carcinoma; Pancreatic Cancer Stage III; Pancreatic Cancer Non-resectable; Pancreatic Adenocarcinoma; Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer Stage I; Pancreatic Cancer Stage; Pancreatic Cancer, Adult; Pancreatic Neoplasms
• Interventions: Diagnostic Test: PANcreatic cancer Exosome Early detectiON (PANXEON)

• Registration Number: NCT06388967
• Lead Sponsor: City of Hope Medical Center

Brief 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 accurately identifying PDAC at its earliest stages.

Study Timeline

• Study Start: 2023-03-15
• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-24
• Study First Posted: 2024-04-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-11-21
• Study Completion: 2025-11-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Histological diagnosis of pancreatic ductal adenocarcinoma, stages I-IV (TNM classification, 8th edition)
• Received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.
• Imaging- or endoscopy-based proof of lack of pancreatic ductal adenocarcinoma at the time of sampling (Non-disease controls)

Exclusion Criteria

• Lack of written informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Pancreatic Cancer Ductal Adenocarcinoma (Validation)	PANcreatic cancer Exosome Early detectiON (PANXEON)	Individuals diagnosed with pancreatic ductal adenocarcinoma
Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Validation)	PANcreatic cancer Exosome Early detectiON (PANXEON)	Individuals without pancreatic ductal adenocarcinoma
Patients with Pancreatic Cancer Ductal Adenocarcinoma (Training)	PANcreatic cancer Exosome Early detectiON (PANXEON)	Individuals diagnosed with pancreatic ductal adenocarcinoma
Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Training)	PANcreatic cancer Exosome Early detectiON (PANXEON)	Individuals without pancreatic ductal adenocarcinoma

Primary Outcome Measures

Name	Time	Method
Sensitivity	Through study completion, an average of 1 year	True positive rate: the probability of a positive test result, conditioned on the individual truly being positive

Secondary Outcome Measures

Name	Time	Method
Specificity	Through study completion, an average of 1 year	True negative rate: the probability of a negative test result, conditioned on the individual truly being negative
Accuracy	Through study completion, an average of 1 year	A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined

Trial Locations

Locations (11)

Nagoya University; 🇯🇵 Nagoya, Japan

Ochsner Medical Center; 🇺🇸 Jefferson, Louisiana, United States

Hoag Center; 🇺🇸 Newport Beach, California, United States

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Atlantic Health System; 🇺🇸 Morristown, New Jersey, United States

Piedmont Medical Center; 🇺🇸 Rock Hill, South Carolina, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Translational Genomics Research Institute; 🇺🇸 Phoenix, Arizona, United States

Honorhealth; 🇺🇸 Scottsdale, Arizona, United States

City of Hope Medical Center; 🇺🇸 Monrovia, California, United States

OSF HealthCare; 🇺🇸 Peoria, Illinois, United States