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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05625529
Other study ID # BioDyn-011
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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