ExoLuminate Study for Early Detection of Pancreatic Cancer
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05625529 |
|
Recruitment Status :
Recruiting
First Posted : November 23, 2022
Last Update Posted : November 28, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease |
|---|
| Pancreas Cancer Exosomes Extracellular Vesicles Pancreatic Neoplasms |
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] |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 3 Years |
| 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 |
| Actual Study Start Date : | December 19, 2022 |
| Estimated Primary Completion Date : | January 1, 2026 |
| Estimated Study Completion Date : | January 1, 2027 |
| Group/Cohort |
|---|
|
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. |
- Clinical performance of ExoVerita™ assay [ Time Frame: 36 months or until diagnostic resolution ]Specificity
- 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
Biospecimen Retention: Samples Without DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
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.
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
| Contact: Harmeet Dhani, MD, M.Sc | 858-202-6150 | exoluminate@biologicaldynamics.com |
| United States, California | |
| University of California, San Diego | Recruiting |
| La Jolla, California, United States, 92093 | |
| Contact: Rebekah White, MD | |
| Biological Dynamics | Recruiting |
| San Diego, California, United States, 92121 | |
| Contact: Harmeet Dhani, MD | |
| Contact 858-202-6150 | |
| Saint John's Cancer Institute at Providence Saint John's Health Center | Recruiting |
| Santa Monica, California, United States, 90404 | |
| Contact: Hoon David, PhD | |
| Contact 310-449-5267 | |
| Dr. Lomis Comprehensive Surgical Center | Recruiting |
| Van Nuys, California, United States, 91405 | |
| Contact: Thomas Lomis, MD | |
| United States, District of Columbia | |
| MedStar Health Research Institute | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Priyanka Kanth, MD | |
| United States, Florida | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Steven Hughes, MD | |
| Bhanu Visvalingam | Recruiting |
| Port Orange, Florida, United States, 32127 | |
| Contact: Bhanu Visvalingam, MD | |
| Contact 386-304-7070 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02136 | |
| Contact: Sapna Syngal, MD | |
| Contact 857-215-1892 | |
| Principal Investigator: | Harmeet Dhani, MD, M.Sc | Biological Dynamics |
Publications:
| 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: | November 28, 2023 |
| Last Verified: | November 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Early Detection Exosomes Extracellular Vesicles |
IPMN PDAC Pancreatic Cancer |
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |