An observational study in Pancreatic Cancer, Pancreatic Carcinoma and Pancreatic Adenocarcinoma, sponsored by City of Hope Medical Center. Recruiting at 13 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by City of Hope Medical Center · Observational
This study aims to prospective validate an exosome-based miRNA signature for noninvasive and early detection of pancreatic ductal adenocarcinoma.
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.
Independent cohorts of individuals with and without pancreatic cancer (cases and controls, respectively)
Exclusion Criteria:
Individuals diagnosed with pancreatic ductal adenocarcinoma
Diagnostic Test: PANcreatic cancer Exosome Early detectiON (PANXEON)
Individuals without pancreatic ductal adenocarcinoma
Diagnostic Test: PANcreatic cancer Exosome Early detectiON (PANXEON)
Individuals diagnosed with pancreatic ductal adenocarcinoma
Diagnostic Test: PANcreatic cancer Exosome Early detectiON (PANXEON)
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
Also known as: PANXEON (PANcreatic cancer Exosome Early detectiON)
Sensitivity
True positive rate: the probability of a positive test result, conditioned on the individual truly being positive
Time frame: Through study completion, an average of 1 year
Specificity
True negative rate: the probability of a negative test result, conditioned on the individual truly being negative
Time frame: Through study completion, an average of 1 year
Accuracy
A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined
Time frame: Through study completion, an average of 1 year
Plan to share: Undecided — 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
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