2023-03-15
2025-11-21
2025-11-21
2000
NCT06388967
City of Hope Medical Center
City of Hope Medical Center
OBSERVATIONAL
Pancreatic Cancer Detection Consortium
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 accurately identifying PDAC at its earliest stages.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2024-04-19 | N/A | 2025-04-29 |
2024-04-24 | N/A | 2025-05-01 |
2024-04-29 | N/A | 2025-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
: Patients with Pancreatic Cancer Ductal Adenocarcinoma (Training) Individuals diagnosed with pancreatic ductal adenocarcinoma | DIAGNOSTIC_TEST: PANcreatic cancer Exosome Early detectiON (PANXEON)
|
: Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Training) Individuals without pancreatic ductal adenocarcinoma | DIAGNOSTIC_TEST: PANcreatic cancer Exosome Early detectiON (PANXEON)
|
: Patients with Pancreatic Cancer Ductal Adenocarcinoma (Validation) Individuals diagnosed with pancreatic ductal adenocarcinoma | |
: Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Validation) Individuals without pancreatic ductal adenocarcinoma | DIAGNOSTIC_TEST: PANcreatic cancer Exosome Early detectiON (PANXEON)
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Sensitivity | True positive rate: the probability of a positive test result, conditioned on the individual truly being positive | Through study completion, an average of 1 year |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Specificity | True negative rate: the probability of a negative test result, conditioned on the individual truly being negative | 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 | Through study completion, an average of 1 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact Name: Ajay Goel, PhD Phone Number: 6262183452 Email: AJGOEL@COH.ORG |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.