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NCT Number: NCT06388967

Pancreatic Cancer Detection Consortium

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PANcreatic cancer Exosome Early detectiON (PANXEON)

Diagnostic Test

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ajay Goel, PhD

CONTACT

[email protected]

6262183452

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Registry information

Official study title

Early Detection of Pancreatic Cancer: Prospective Study

Acronym: PCDC

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Apr 29, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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