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An Exosome-based and Machine-learning-powered Liquid Biopsy for Pancreatic Cancer Early-detection and Disease Monitoring

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
View:

• 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

Locations
Other Locations
Italy
IRCCS San Raffaele Hospital
RECRUITING
Milan
Contact Information
Primary
Alessandro Mannucci, MD
mannucci.alessandro@hsr.it
0226437262
Time Frame
Start Date: 2026-06-03
Estimated Completion Date: 2032-01-30
Participants
Target number of participants: 600
Treatments
Familial pancreatic cancer (FPC)
This term refers to individuals who are at a higher risk of developing pancreatic cancer based on their family history. There are two main risk categories:~* 2 relatives with pancreatic cancer, who are first-degree relative of each other, and at least one should be a first degree relative of the individual for whom surveillance is being considered~* 3 or more relatives with pancreatic cancer, regardless of the degree
Hereditary pancreatic cancer (HPC)
This terms encompasses all individuals who are at an increased risk of developing pancreatic cancer based on the presence of a pathogenic (or likely pathogenic) germline variant. More specifically:~* All individuals with a pathogenic (or likely pathogenic) germline variant in Serine/Threonine Kinase 11 (STK11), cyclin-dependent kinase inhibitor 2A (CDKN2A), Ataxia-Telangiectasia Mutated (ATM), and Breast cancer type 2 (BRCA2) genes, regardless of their family history of pancreatic cancer~* Individuals who have both (i) a pathogenic (or likely pathogenic) germline variant in Breast cancer type 1 (BRCA1), Partner and Localizer of BRCA2 (PALB2), Mutator L Homolog 1 (MLH1), Mutator S Homolog 2 (MSH2), Mutator S Homolog 6 (MSH6), Postmeiotic Segregation 1 Homolog 2 (PMS2), or Epithelial Cell Adhesion Molecule (EPCAM) genes; and (ii) at least one relative diagnosed with pancreatic cancer
Mucinous Pancreatic Neoplasms (MPN)
This term refers collectively to cystic lesions of the pancreas that confer an increased risk of developing pancreatic cancer. Collectively, this term encompasses both Intraductal Pancreatic Mucinous Neoplasms (IPMN) and Mucinous Cystic Neoplasias (MCNs)
Sponsors
Leads: Università Vita-Salute San Raffaele

This content was sourced from clinicaltrials.gov