Clinical Studies

1.  Pancreatic Cancer Early Detection Consortium - UCSD site

The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic cancer by establishing a multisite cohort of individuals with family history of pancreatic cancer and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to pancreatic cancer risk for longitudinal follow up. The main objective of the PRECEDE Consortium is to build a shared resource to drive research in critical areas necessary for early detection and prevention of pancreatic cancer.

The PRECEDE Consortium is an observational prospective cohort study, with single or serial biosample collection (every 6-12 months) in defined high-risk groups. A standardized procedure for collection and processing of human blood for the PRECEDE Consortium will be applied to all blood samples collected as part of the study. Barcoded samples will be stored at the clinical centers, using the specific labels for the PRECEDE study and corresponding data will be entered into the study database.

Study enrollment at UCSD is managed through our Pancreatic Cancer Early Detection and Prevention Clinic. UCSD is the academic coordinating center and primary clinical site for the PRECEDE study. 

2. Biomarker Validation in Pancreatic Cystic Neoplasms (NIH U01CA282272)

Pancreatic cystic neoplasms are common in the population. The goal of this project is to study biomarkers from blood and cyst fluid that could help clinicians better distinguish which pancreas cysts are the most likely to progress to cancer and require close follow up. This study is open to individuals at UCSD Health with pancreas cysts 2.5 cm or larger, main pancreatic duct dilation of 5 mm or greater, or a pancreas cyst that is recommended to be surgically removed. Participants can also enroll at collaborating sites at the University of Pittsburgh, Penn Medicine, and the University of Miami.  

3. Missing Heritability in Familial Pancreatic Cancer 

Currently, 85% of families with two or more first degree relatives affected with pancreatic cancer (familial pancreatic cancer, FPC) do not have a genetic risk factor identifiable with presently available testing. It is clear that better understanding of the underlying heritability of pancreatic cancer will be necessary for improved risk stratification and early detection efforts.

While the search for high-risk alleles in FPC kindred has been ongoing for several years, recent improvements in sample collection from high-risk families and advances in sequencing technologies and analytics could lead to new discoveries. We are partnering on this work with academic collaborators including Giovanni Parmigiani (Harvard/DFCI), Ludmil Alexandrov (UCSD), and scientific partners at Ambry Genetics and PacBio.   

The Pancreatic Cancer Early Detection Consortium (PRECEDE) is an international,  multi-institutional collaborative group of experts working to increase survival for pancreatic cancer patients by improving early detection, screening, risk modeling and prevention for those with a heritable risk for pancreatic cancer, through a novel model of collaboration and data sharing. PRECEDE’s mission is to transform the early detection and prevention of pancreatic cancer, with the aim of increasing the 5-year survival rate from 10% to 50% within the next 10 years. UCSD is the academic coordinating center for this international effort. Dr. Simeone serves as the overall study PI and chair of the Executive Committee. 

Click on the logo below to learn more about PRECEDE!

The Global Coalition for Adaptive Research (GCAR) and the Pancreatic Cancer Action Network (PanCAN) formed an alliance to develop the Innovative Master Protocol to Accelerate Clinical Therapeutics for Pancreatic Ductal Adenocarcinoma (IMPACT PDAC). This collaboration builds on the previous Precision Promise platform (2020-2024), and will continue to accelerate research to address the urgent need for new and more effective therapies for pancreatic cancer patients. 

​IMPACT PDAC builds on the novel clinical trial platform created for Precision Promise to more efficiently test new therapies for their effectiveness in treating patients with pancreatic cancer by requiring fewer patients to understand if a potential new therapy is working. The new collaboration between PanCAN and GCAR allows for increased efficiency and scalability, and potential to reach a broader and more diverse patient population. 

Dr. Simeone served as chair of the national steering committee and institutional PI for Precision Promise, and continues to serve as a scientific and medical advisor for the IMPACT PDAC effort.