Exosomes, Extracellular Vesicles, Pancreas Cancer, Pancreatic Neoplasms
Conditions
Keywords
Early Detection, Exosomes, Extracellular Vesicles, IPMN, PDAC, Pancreatic Cancer
Brief summary
ExoLuminate is a nationally-enrolling registry study designed for earlier detection of cancer in patients at elevated risk or clinically-suspicious for pancreatic ductal adenocarcinoma (PDAC). Those with elevated risk for PDAC can include individuals with intraductal papillary mucinous neoplasms, family history of pancreatic cancer, germline mutations in genes known to be associated with cancer, and a personal or family history of pancreatitis. The goal of the study is to compare the performance of ExoVerita™ assay in early detection of PDAC to current standard-of-care methods of surveillance.
Detailed description
Biological Dynamics, Inc. has developed a non-invasive blood test (liquid biopsy) that can identify early-stage disease with high sensitivity and specificity. The proprietary ExoVerita™ assay uses alternating current electric (ACE) field to isolate extracellular vesicles (EVs) for differentiated multiomics applications and includes an optimized machine learning algorithm to identify a panel of EV-bound protein biomarkers in patient's plasma in order to detect PDAC at earlier stages. ExoLuminate is a prospective, multi-center, observational registry study designed to evaluate the non-inferiority of the performance of the ExoVerita™ assay in detecting pancreatic ductal adenocarcinoma (PDAC) in high-risk or clinically-suspicious populations in comparison to standard-of-care methods. The study is planned to recruit a minimum of 1000 U.S. adults over 3-years (with a 2-year follow-up for data collection). Eligible subjects will be evaluated using the ExoVerita™ assay through blood donation(s) at specified time intervals. Overall, this study poses minimal risk to subject.
Interventions
None listed
Sponsors
Biological Dynamics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years old. * Meeting criteria for one of the study cohorts. * Capable of giving informed consent. * Able to provide a blood sample.
Exclusion criteria
* \< 18 years old. * Pregnancy. * Active cancer (other than pancreatic cancer) and/or undergoing treatment for an active cancer diagnosis (except for skin malignancies). * Prior organ transplant or bone marrow transplant. * History of fainting or other adverse effects when blood is drawn. * Any condition that, in the opinion of the investigator, should preclude enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance of ExoVerita™ assay | 36 months or until diagnostic resolution | Specificity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance of ExoVerita™ assay | 36 months or until diagnostic resolution | Sensitivity |
| Stage Shift | 36 months or until diagnostic resolution | Evaluation of stage distribution (SEER) at diagnosis |
Countries
United States
Contacts
Primary ContactHarmeet Dhani, MD, M.Sc
Outcome results
None listed