Early detection of pancreatic cancer using exosome-based biomarkers
Early Detection of Pancreatic Cancer: Prospective Study
This study is testing a new way to find pancreatic cancer early by looking at tiny particles in the blood that carry specific markers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Locations | 11 sites (Phoenix, Arizona and 10 other locations) |
| Trial ID | NCT06388967 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a novel method for the noninvasive early detection of pancreatic ductal adenocarcinoma (PDAC) by analyzing exosomes that contain specific microRNAs. The researchers have previously identified a combination of 13 miRNAs that can accurately detect early-stage PDAC. In this larger international cohort study, they will test the effectiveness of this exosome-based miRNA signature in identifying PDAC at its earliest stages. The study will include patients with histologically confirmed PDAC and non-disease controls who have undergone standard diagnostic procedures.
Who should consider this trial
Good fit: Ideal candidates include individuals with a histological diagnosis of pancreatic ductal adenocarcinoma at any stage and those who have undergone standard diagnostic procedures.
Not a fit: Patients who do not have pancreatic ductal adenocarcinoma or those who cannot provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate detection of pancreatic cancer, improving treatment outcomes for patients.
How similar studies have performed: Previous studies have shown promise in using exosome-based miRNA signatures for cancer detection, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Phoenix, Arizona and 10 other locations
- Translational Genomics Research Institute — Phoenix, Arizona, United States (Recruiting)
- Honorhealth — Scottsdale, Arizona, United States (Recruiting)
- City of Hope Medical Center — Monrovia, California, United States (Recruiting)
- Hoag Center — Newport Beach, California, United States (Recruiting)
- OSF HealthCare — Peoria, Illinois, United States (Recruiting)
- Ochsner Medical Center — Jefferson, Louisiana, United States (Recruiting)
- Atlantic Health System — Morristown, New Jersey, United States (Recruiting)
- Piedmont Medical Center — Rock Hill, South Carolina, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
- Nagoya University — Nagoya, Japan (Recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Ajay Goel, PhD — City of Hope Medical Center
- Study coordinator: Ajay Goel, PhD
- Email: AJGOEL@COH.ORG
- Phone: 6262183452
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.