Early Detection of Pancreatic Cancer: Prospective Study
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.
Arms & interventions
- Diagnostic TestPANcreatic 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
Outcome measures
Primary
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
Secondary
Specificity
Time frame: Through study completion, an average of 1 year
Accuracy
Time frame: Through study completion, an average of 1 year
Eligibility criteria
Study locations (9)
Translational Genomics Research Institute
Phoenix, Arizona, 85004
Honorhealth
Scottsdale, Arizona, 85258
City of Hope Medical Center
Monrovia, California, 91016
Hoag Center
Newport Beach, California, 92663
OSF HealthCare
Peoria, Illinois, 61637
Ochsner Medical Center
Jefferson, Louisiana, 70121
Atlantic Health System
Morristown, New Jersey, 07960
Piedmont Medical Center
Rock Hill, South Carolina, 29732
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
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