Pancreatic Adenocarcinoma, Pancreatic Cancer, Pancreatic Cancer, Adult, Pancreatic Cancer Non-resectable, Pancreatic Cancer Resectable, Pancreatic Cancer Stage, Pancreatic Cancer Stage 0, Pancreatic Cancer Stage I, Pancreatic Cancer Stage II, Pancreatic Cancer Stage III, Pancreatic Carcinoma, Pancreatic Ductal Adenocarcinoma, Pancreatic Neoplasms
Conditions
Keywords
Micro RNA, Exosome, Cell free, Early detection, Screening
Brief 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.
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
Sponsors
City of Hope Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | 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
| Measure | Time frame | Description |
|---|---|---|
| Specificity | 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 |
| Accuracy | 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 |
Countries
Japan, South Korea, United States
Contacts
CONTACTAjay Goel, PhD
PRINCIPAL_INVESTIGATORAjay Goel, PhD
City of Hope Medical Center
Outcome results
None listed