ExoLuminate Study for Early Detection of Pancreatic Cancer

• ClinicalTrials.gov Identifier: NCT05625529
• Recruitment Status: Recruiting
• First Posted: November 23, 2022
• Last Update Posted: November 28, 2023
• Sponsor: Biological Dynamics
• Collaborators: Medical College of Wisconsin; Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Harmeet Dhani, Biological Dynamics

Tracking Information

• First Submitted Date: November 15, 2022
• First Posted Date: November 23, 2022
• Last Update Posted Date: November 28, 2023
• Actual Study Start Date: December 19, 2022
• Estimated Primary Completion Date: January 1, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 22, 2023)

Clinical performance of ExoVerita™ assay [ Time Frame: 36 months or until diagnostic resolution ]

Specificity

Original Primary Outcome Measures (submitted: November 15, 2022)

Clinical performance of ExoVerita™ assay [ Time Frame: 24 months or until diagnostic resolution ]

Specificity

Current Secondary Outcome Measures (submitted: November 22, 2023)

• Clinical performance of ExoVerita™ assay [ Time Frame: 36 months or until diagnostic resolution ]
  Sensitivity
• Stage Shift [ Time Frame: 36 months or until diagnostic resolution ]
  Evaluation of stage distribution (SEER) at diagnosis

Original Secondary Outcome Measures (submitted: November 15, 2022)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 3 Years

Biospecimen

Retention:   Samples Without DNA

Description:

Double-spun plasma, EDTA tubes

• 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.

Condition

• Pancreas Cancer
• Exosomes
• Extracellular Vesicles
• Pancreatic Neoplasms

• Intervention: Not Provided

Study Groups/Cohorts

• Cohort 1

  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

  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
  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
  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

  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

  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

  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

  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.

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 15, 2022): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2027
• Estimated Primary Completion Date: January 1, 2026 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Harmeet Dhani, MD, M.Sc; 858-202-6150; exoluminate@biologicaldynamics.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05625529
• Other Study ID Numbers: BioDyn-011
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Harmeet Dhani, Biological Dynamics
• Original Responsible Party: Harmeet Dhani, Biological Dynamics, Harmeet Dhani, M.D., M.Sc
• Current Study Sponsor: Biological Dynamics
• Original Study Sponsor: Same as current

Collaborators

• Medical College of Wisconsin
• Dana-Farber Cancer Institute

Investigators

• Principal Investigator: Harmeet Dhani, MD, M.Sc; Biological Dynamics

• PRS Account: Biological Dynamics
• Verification Date: November 2023