Trial Title:
ExoLuminate Study for Early Detection of Pancreatic Cancer
NCT ID:
NCT05625529
Condition:
Pancreas Cancer
Exosomes
Extracellular Vesicles
Pancreatic Neoplasms
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Early Detection
Exosomes
Extracellular Vesicles
IPMN
PDAC
Pancreatic Cancer
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Individuals at high risk of pancreatic cancer or with stage I-II pancreatic cancer (or
clinical suspicion). See cohorts under Groups and Interventions for details.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Diego
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rebekah White, MD
Facility:
Name:
Biological Dynamics
Address:
City:
San Diego
Zip:
92121
Country:
United States
Status:
Recruiting
Contact:
Last name:
Harmeet Dhani, MD
Contact backup:
Phone:
858-202-6150
Facility:
Name:
Saint John's Cancer Institute at Providence Saint John's Health Center
Address:
City:
Santa Monica
Zip:
90404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hoon David, PhD
Contact backup:
Phone:
310-449-5267
Facility:
Name:
Dr. Lomis Comprehensive Surgical Center
Address:
City:
Van Nuys
Zip:
91405
Country:
United States
Status:
Recruiting
Contact:
Last name:
Thomas Lomis, MD
Facility:
Name:
MedStar Health Research Institute
Address:
City:
Washington
Zip:
20010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Priyanka Kanth, MD
Facility:
Name:
University of Florida
Address:
City:
Gainesville
Zip:
32610
Country:
United States
Status:
Recruiting
Contact:
Last name:
Steven Hughes, MD
Facility:
Name:
Bhanu Visvalingam
Address:
City:
Port Orange
Zip:
32127
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bhanu Visvalingam, MD
Contact backup:
Phone:
386-304-7070
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sapna Syngal, MD
Contact backup:
Phone:
857-215-1892
Start date:
December 19, 2022
Completion date:
January 1, 2027
Lead sponsor:
Agency:
Biological Dynamics
Agency class:
Industry
Collaborator:
Agency:
Medical College of Wisconsin
Agency class:
Other
Collaborator:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Source:
Biological Dynamics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05625529
https://biologicaldynamics.com/
https://www.ExoLuminate.com
