ExoLuminate Study for Early Detection of Pancreatic Cancer

Sponsor

Biological Dynamics (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05625529

Collaborator

(none)

1,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

ExoLuminate is a nationally-enrolling registry study designed for earlier detection of cancer in those patients that are at an elevated risk or clinically-suspicious for pancreatic ductal adenocarcinoma (PDAC).

Those with elevated risk for PDAC can include individuals with intraductal papillary mucinous neoplasms, a family history of pancreatic cancer, germline mutations in genes known to be associated with cancer, a personal or family history of pancreatitis, or new onset diabetes after age 50.

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Cancer Exosomes Extracellular Vesicles Pancreatic Neoplasms

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 2-years (with a 1-year follow-up for data collection).

The test will be ordered through providers. 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1: High-Risk Population Intraductal papillary mucinous neoplasms (IPMNs) Family member(s) who have at least one first-degree relative (FDR) affected by pancreatic cancer, Germline mutations in genes known to be associated with cancer, including BRCA1, BRCA2, PALB2, CDKN2A, ATM, TP53, STK11, MLH1, MSH2, MSH6, PMS2, PRSS1, EPCAM. Personal or family history of pancreatitis New-onset Diabetes (NOD)
Cohort 2: Clinically-suspicious PDAC or Pathologically-confirmed Clinical findings suspicious for early stage PDAC Biopsy-proven, clinical stage I-IV PDAC

Arm

Intervention/Treatment

Cohort 1: High-Risk Population

Intraductal papillary mucinous neoplasms (IPMNs) Family member(s) who have at least one first-degree relative (FDR) affected by pancreatic cancer, Germline mutations in genes known to be associated with cancer, including BRCA1, BRCA2, PALB2, CDKN2A, ATM, TP53, STK11, MLH1, MSH2, MSH6, PMS2, PRSS1, EPCAM. Personal or family history of pancreatitis New-onset Diabetes (NOD)

Cohort 2: Clinically-suspicious PDAC or Pathologically-confirmed

Clinical findings suspicious for early stage PDAC Biopsy-proven, clinical stage I-IV PDAC

Outcome Measures

Primary Outcome Measures

Clinical performance of ExoVerita™ assay [24 months or until diagnostic resolution]
Specificity

Secondary Outcome Measures

Clinical performance of ExoVerita™ assay [24 months or until diagnostic resolution]
Sensitivity
Stage Shift [24 months or until diagnostic resolution]
Evaluation of stage distribution (SEER) at diagnosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥18 years old
Cohort 1 or Cohort 2
Capable of giving informed consent
Able to provide a blood sample
Tested for the presence of deleterious germline mutations associated with PDAC or willing to provide samples for germline genetic analysis.

Exclusion Criteria:

< 18 years old
Pregnancy
Undergoing any active treatment from of an active cancer diagnosis (except for skin malignancies).
History of fainting or other adverse effects when blood is drawn.
Unwilling to provide germline mutation information or samples for germline genetic analysis
Any condition that, in the opinion of the investigator, should preclude enrollment.