A Liquid Biopsy for Pancreatic Cancer Early-detection and Disease Monitoring
Recruiting · NCT07700992 · Observational (researchers observe without assigning treatment) · Lead sponsor: Università Vita-Salute San Raffaele
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Pancreatic ductal adenocarcinoma (PDAC) is a highly lethal malignancy characterized by an asymptomatic early phase, late diagnosis, and poor survival, particularly in individuals who develop disease outside the context of early-stage detection. Early detection strategies are currently limited to imaging-based surveillance (MRI and endoscopic ultrasound) in selected high-risk populations, but these approaches are invasive, costly, and suboptimal in sensitivity. The aim of this study is to evaluate circulating cell-free and exosome-bound microRNAs as non-invasive biomarkers of PDAC risk and disease biology
Who can take part
Inclusion criteria
- Adult men or women aged ≥18 years at the time of plasma sample collection.
- Classification as at increased risk for pancreatic ductal adenocarcinoma (PDAC) due to familial pancreatic cancer or hereditary pancreatic cancer syndrome
- Classification as at increased risk for pancreatic ductal adenocarcinoma (PDAC) due to the presence of one (or more) mucinous pancreatic cystic lesion(s).
- Availability of stored plasma samples collected as part of routine clinical care or surveillance and archived in the institutional biobank.
- Availability of relevant clinical and demographic data in institutional medical records sufficient to address study objectives.
- Prior provision of informed consent for biobanking and research use of biological samples and data
Exclusion criteria
- Absence or insufficient quality/quantity of stored plasma samples for laboratory analysis.
- Lack of clinical data required for cohort classification and/or outcome assessment.
- History of pancreatic surgery or interventional procedures prior to plasma sample collection.
- Concurrent active malignancy at the time of sample collection, other than non-melanoma skin cancer.
- Samples collected outside routine clinical care or not compliant with institutional biobanking and data protection policies.
Where it is running
1 location listed.
- IRCCS San Raffaele Hospital - Milan, MI, Italy