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Trial record 1 of 1 for:    NCT05625529
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ExoLuminate Study for Early Detection of Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT05625529
Recruitment Status : Not yet recruiting
First Posted : November 23, 2022
Last Update Posted : December 8, 2022
Sponsor:
Information provided by (Responsible Party):
Harmeet Dhani, Biological Dynamics

Study Description
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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
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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
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
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : January 1, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Clinical performance of ExoVerita™ assay [ Time Frame: 24 months or until diagnostic resolution ]
    Specificity


Secondary Outcome Measures :
  1. Clinical performance of ExoVerita™ assay [ Time Frame: 24 months or until diagnostic resolution ]
    Sensitivity

  2. Stage Shift [ Time Frame: 24 months or until diagnostic resolution ]
    Evaluation of stage distribution (SEER) at diagnosis


Biospecimen Retention:   Samples Without DNA
Double-spun plasma, EDTA tubes

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cohort 1 -

  1. IPMN lesions, any age.
  2. Family member(s) who have at least one FDR affected by PDAC, Age ≥50 (or 10 years earlier than youngest afflicted relative)
  3. STK11 (Peutz-Jeghers syndrome), any age.
  4. CDKN2A, p16 (Familial atypical multiple mole and melanoma; FAMMM), any age.
  5. BRCA1, BRCA2, ATM, PALB2, ≥45 (or 10 years earlier than youngest afflicted relative)
  6. MLH1, MSH2, MSH6, PMS2, EPCAM, TP53 (HNPCC), Age ≥50 (or 10 years earlier than youngest afflicted relative)
  7. Hereditary Pancreatitis with confirmed PRSS1. Age ≥40
  8. Acute, Chronic, or Hereditary Pancreatitis, any age.
  9. New-onset diabetes, age ≥50

Cohort 2 -

  1. Clinical findings suspicious for early stage PDAC OR
  2. Biopsy-proven, clinical stage I-IV PDAC
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05625529


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

Sponsors and Collaborators
Biological Dynamics
Investigators
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Principal Investigator: Harmeet Dhani, MD, M.Sc Biological Dynamics
More Information
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Additional Information:

Publications:

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Responsible Party: Harmeet Dhani, Medical Director, Biological Dynamics
ClinicalTrials.gov Identifier: NCT05625529    
Other Study ID Numbers: BioDyn-011
First Posted: November 23, 2022    Key Record Dates
Last Update Posted: December 8, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Harmeet Dhani, Biological Dynamics:
Early Detection
Exosomes
Extracellular Vesicles
 IPMN
PDAC
Pancreatic Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases