ExoLuminate Study for Early Detection of Pancreatic Cancer

NCT05625529 | Recruiting

• 1 other identifier: BioDyn-011
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer; Exosomes; Extracellular Vesicles; Pancreatic Neoplasms

Keywords

Early Detection; Exosomes; Extracellular Vesicles; IPMN; PDAC; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical performance of ExoVerita™ assay

  Specificity

  36 months or until diagnostic resolution

Secondary Outcomes (2)

• Clinical performance of ExoVerita™ assay

  36 months or until diagnostic resolution

• Stage Shift

  36 months or until diagnostic resolution

Study Arms (8)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥18 years old.
• Meeting criteria for one of the study cohorts.
• Capable of giving informed consent.
• Able to provide a blood sample.

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• Biological Dynamics: lead

Study Sites (1)

Biological Dynamics

San Diego, California, 92121, United States

RECRUITING

Related 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.

  PMID: 35603292 BACKGROUND

• 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.

  PMID: 37857666 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Double-spun plasma, EDTA tubes

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Harmeet Dhani, MD, M.Sc

  Biological Dynamics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harmeet Dhani, MD, M.Sc

CONTACT

858-202-6150; exoluminate@biologicaldynamics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: December 19, 2022
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

US (1)