ExoLuminate Study for Early Detection of Pancreatic Cancer

Pancreas Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625529
• Other study ID #: BioDyn-011
• Status: Recruiting
• Start date: December 19, 2022
• Est. completion date: January 1, 2027

Study information

• Verified date: November 2023
• Source: Biological Dynamics
• Contact: Harmeet Dhani, MD, M.Sc
• Phone: 858-202-6150
• Email: exoluminate[@]biologicaldynamics.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Exosomes
• Extracellular Vesicles
• Pancreas Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Florida	Gainesville	Florida
United States	University of California, San Diego	La Jolla	California
United States	Bhanu Visvalingam	Port Orange	Florida
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

Sponsors (3)

Lead Sponsor	Collaborator
Biological Dynamics	Dana-Farber Cancer Institute, Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance of ExoVerita™ assay	Specificity	36 months or until diagnostic resolution
Secondary	Clinical performance of ExoVerita™ assay	Sensitivity	36 months or until diagnostic resolution
Secondary	Stage Shift	Evaluation of stage distribution (SEER) at diagnosis	36 months or until diagnostic resolution

External Links

•   Biological Dynamics, Inc. Website
•   ExoLuminate Study Website for Providers