Pancreatic Cancer Detection Consortium

Brief summary public domain (ClinicalTrials.gov)

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

Detailed description public domain (ClinicalTrials.gov)

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.

Intervention public domain (ClinicalTrials.gov)

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

Arm public domain (ClinicalTrials.gov)

Patients with Pancreatic Cancer Ductal Adenocarcinoma (Training) (): Individuals diagnosed with pancreatic ductal adenocarcinoma

Arm public domain (ClinicalTrials.gov)

Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Training) (): Individuals without pancreatic ductal adenocarcinoma

Arm public domain (ClinicalTrials.gov)

Patients with Pancreatic Cancer Ductal Adenocarcinoma (Validation) (): Individuals diagnosed with pancreatic ductal adenocarcinoma

Arm public domain (ClinicalTrials.gov)

Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Validation) (): Individuals without pancreatic ductal adenocarcinoma

Primary outcome public domain (ClinicalTrials.gov)

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 outcome public domain (ClinicalTrials.gov)

Specificity. Time frame: Through study completion, an average of 1 year.

Secondary outcome public domain (ClinicalTrials.gov)

Accuracy. Time frame: Through study completion, an average of 1 year.

Eligibility public domain (ClinicalTrials.gov)

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.

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 2000 participants (estimated).