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Spots Global Cancer Trial Database for ExoLuminate Study for Early Detection of Pancreatic Cancer

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Trial Identification

Brief Title: ExoLuminate Study for Early Detection of Pancreatic Cancer

Official Title: Exoluminate Study: Observational Registry Study to Assess Exo-PDAC Assay Performance for Detection of Pancreatic Adenocarcinoma (PDAC) in High-Risk or Clinically Suspicious Patients

Study ID: NCT05625529

Interventions

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of California, San Diego, La Jolla, California, United States

Biological Dynamics, San Diego, California, United States

Saint John's Cancer Institute at Providence Saint John's Health Center, Santa Monica, California, United States

Dr. Lomis Comprehensive Surgical Center, Van Nuys, California, United States

MedStar Health Research Institute, Washington, District of Columbia, United States

University of Florida, Gainesville, Florida, United States

Bhanu Visvalingam, Port Orange, Florida, United States

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Contact Details

Name: Harmeet Dhani, MD, M.Sc

Affiliation: Biological Dynamics

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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