Clinical trial NCT05625529: 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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Cancer
Exosomes
Extracellular Vesicles
Pancreatic Neoplasms
Keywords: Early Detection
Exosomes
Extracellular Vesicles
IPMN
PDAC
Pancreatic Cancer
Lead sponsor: Biological Dynamics
Sponsor class: INDUSTRY
Collaborators: name: Medical College of Wisconsin
name: Dana-Farber Cancer Institute
First posted: 2022-11-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 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.

Primary outcomes:
measure: Clinical performance of ExoVerita™ assay
timeFrame: 36 months or until diagnostic resolution
Secondary outcomes:
measure: Clinical performance of ExoVerita™ assay
timeFrame: 36 months or until diagnostic resolution
measure: Stage Shift
timeFrame: 36 months or until diagnostic resolution
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: San Diego
country: United States
facility: Biological Dynamics
state: California
city: Santa Monica
country: United States
facility: Saint John's Cancer Institute at Providence Saint John's Health Center
state: California
city: Van Nuys
country: United States
facility: Dr. Lomis Comprehensive Surgical Center
state: California
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Port Orange
country: United States
facility: Bhanu Visvalingam
state: Florida
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Biological Dynamics
name: Harmeet Dhani, MD, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hinestrosa JP, Kurzrock R, Lewis JM, Schork NJ, Schroeder G, Kamat AM, Lowy AM, Eskander RN, Perrera O, Searson D, Rastegar K, Hughes JR, Ortiz V, Clark I, Balcer HI, Arakelyan L, Turner R, Billings PR, Adler MJ, Lippman SM, Krishnan R. Early-stage multi-cancer detection using an extracellular vesicle protein-based blood test. Commun Med (Lond). 2022 Mar 17;2:29. doi: 10.1038/s43856-022-00088-6. eCollection 2022.
citation: Hinestrosa JP, Sears RC, Dhani H, Lewis JM, Schroeder G, Balcer HI, Keith D, Sheppard BC, Kurzrock R, Billings PR. Development of a blood-based extracellular vesicle classifier for detection of early-stage pancreatic ductal adenocarcinoma. Commun Med (Lond). 2023 Oct 19;3(1):146. doi: 10.1038/s43856-023-00351-4.