ExoLuminate Study for Early Detection of Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreas Cancer, Exosomes, Extracellular Vesicles, Pancreatic Neoplasms

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Individuals without history of PDAC meeting any of the following criteria: A. 2+ relatives with PDAC on same side of family; 2 are first degree related to each other and at least 1 is first degree related to subject; age ≥ 50 years or ≤10 years younger than earliest PDAC in family at diagnosis. B. 2+ first degree relatives with PDAC; age ≥ 50 years or ≤ 10 years younger than earliest PDAC in family at diagnosis. C. BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND 1 first or second degree relative with PDAC; age ≥ 50 years or ≤ 10 years younger than earliest PDAC in family at diagnosis. D. Familial Atypical Moles and Malignant Melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age ≥ 40 years. E. Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age ≥35 years. F. Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age ≥ 40 years. | |
| Cohort 2<br>Individuals without history of PDAC meeting any of the following criteria: A. ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history; age ≥50 years. B. Two or more (2+) relatives with PDAC on the same side of family, any degree of relation, not meeting other criteria above; age ≥50 years or ≤10 years younger than earliest PDAC in family at time of diagnosis. C. One (1) first degree relative with PDAC at age ≤45 years; ≤10 years younger than PDAC diagnosis in family member at time of diagnosis. | |
| Cohort 3<br>A. Individuals meeting criteria for Cohorts 1 or 2 EXCEPT age (i.e. too young to qualify for Cohorts 1 or 2); age ≥ 18 years. | |
| Cohort 4<br>A. Individuals without history of PDAC presenting for evaluation who do not meet any criteria for the other cohorts after collection of full family history and/or germline testing, eg. they have only 1 relative with PDAC; age ≥ 18 years. | |
| Cohort 5 - Personal history of PDAC<br>Individuals with a personal history of PDAC meeting any of the following criteria (age ≥ 18 years for all subgroups): A. Family history includes at least one first degree relative with PDAC, or 2 relatives with PDAC who are first degree related to each other. B. Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, PRSS1, STK11. C. Diagnosed with PDAC at ≤ age 45. | |
| Cohort 6 - Pancreatic cysts<br>Individuals with pancreatic cysts (age ≥ 18 years for all subgroups): A. Individuals with a pancreatic cystic neoplasm (IPMN) and/or mucinous cystic neoplasm (MCN) and/or PanIN not meeting any criteria for Cohorts 1-3 or 6 (no personal history of PDAC, no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk present in cohorts 1C, 2A, 1D, 1E, and 1F). B. Individuals with a pancreatic cystic neoplasm (IPMN) and/or MCN and/or PanIN without PDAC and with at least one of the pathogenic or likely pathogenic gene mutations present in cohorts 1C, 2A, 1D, 1E, and 1F and/or a first degree relative with PDAC. | |
| Cohort 7 - Acute or chronic pancreatitis<br>Individuals with a personal history of pancreatitis meeting any of the following criteria (age ≥ 18 years for all subgroups): A. Chronic pancreatitis. B. At least 2 episodes of acute pancreatitis. | |
| Cohort 8 - PDAC stages I-II or clinical suspicion<br>Individuals with one of the following conditions and treatment naïve (age ≥ 18 years for all subgroups): A. Biopsy-proven, clinical stage I-II PDAC and candidate for surgical resection. B. Clinical findings suspicious for early stage PDAC prior to biopsy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance of ExoVerita™ assay | Specificity | 36 months or until diagnostic resolution | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance of ExoVerita™ assay | Sensitivity | 36 months or until diagnostic resolution | 
| Stage Shift | Evaluation of stage distribution (SEER) at diagnosis | 36 months or until diagnostic resolution | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Detection, Exosomes, Extracellular Vesicles, IPMN, PDAC, Pancreatic Cancer