Pancreatic Cancer Detection Consortium (PCDC)

December 17, 2025 updated by: City of Hope Medical Center

Early Detection of Pancreatic Cancer: Prospective Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Nagoya, Japan
        • Recruiting
        • Nagoya University
        • Sub-Investigator:
          • Yasuhiro Kodera
        • Contact:
        • Sub-Investigator:
          • Masamichi Hayashi
  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Sub-Investigator:
          • Song Cheol Kim
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Recruiting
        • Translational Genomics Research Institute
        • Contact:
        • Principal Investigator:
          • Daniel Von Hoff
        • Sub-Investigator:
          • Haiyong Han
        • Sub-Investigator:
          • Derek Cridebring
      • Scottsdale, Arizona, United States, 85258
    • California
      • Monrovia, California, United States, 91016
        • Recruiting
        • City of Hope Medical Center
        • Contact:
        • Sub-Investigator:
          • Alessandro Mannucci
        • Sub-Investigator:
          • Caiming Xu
        • Principal Investigator:
          • Ajay Goel
        • Sub-Investigator:
          • Stanley Hamilton
        • Sub-Investigator:
          • Vincent Chung
      • Newport Beach, California, United States, 92663
    • Illinois
    • Louisiana
      • Jefferson, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center
        • Contact:
        • Sub-Investigator:
          • John Bolton
    • New Jersey
      • Morristown, New Jersey, United States, 07960
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Piedmont Medical Center
        • Contact:
        • Sub-Investigator:
          • Andrew Page
        • Sub-Investigator:
          • Eyal Meiri
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Sub-Investigator:
          • Douglas Evans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Independent cohorts of individuals with and without pancreatic cancer (cases and controls, respectively)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Pancreatic Cancer Ductal Adenocarcinoma (Training)
Individuals diagnosed with pancreatic ductal adenocarcinoma
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
Other Names:
  • PANXEON (PANcreatic cancer Exosome Early detectiON)
Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Training)
Individuals without pancreatic ductal adenocarcinoma
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
Other Names:
  • PANXEON (PANcreatic cancer Exosome Early detectiON)
Patients with Pancreatic Cancer Ductal Adenocarcinoma (Validation)
Individuals diagnosed with pancreatic ductal adenocarcinoma
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
Other Names:
  • PANXEON (PANcreatic cancer Exosome Early detectiON)
Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Validation)
Individuals without pancreatic ductal adenocarcinoma
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
Other Names:
  • PANXEON (PANcreatic cancer Exosome Early detectiON)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: 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
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: 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
Through study completion, an average of 1 year
Accuracy
Time Frame: 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
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Ajay Goel, PhD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Estimated)

June 18, 2026

Study Completion (Estimated)

June 18, 2026

Study Registration Dates

First Submitted

April 19, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19288/PCDC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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