Early detection of pancreatic cancer using a blood test
Exoluminate Study: Observational Registry Study to Assess Exo-PDAC Assay Performance for Detection of Pancreatic Adenocarcinoma (PDAC) in High-Risk or Clinically Suspicious Patients
Biological Dynamics · NCT05625529
This study is testing a new blood test to see if it can help find pancreatic cancer earlier in people who are at high risk or show signs of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biological Dynamics (industry) |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT05625529 on ClinicalTrials.gov |
What this trial studies
The ExoLuminate study is a national registry aimed at improving early detection of pancreatic ductal adenocarcinoma (PDAC) in individuals at high risk or with clinical suspicion of the disease. It evaluates the effectiveness of the ExoVerita™ assay, a non-invasive blood test that isolates extracellular vesicles to identify biomarkers associated with early-stage PDAC. The study plans to enroll at least 1000 adults over three years, with follow-up data collection extending for two years. Participants will provide blood samples at specified intervals to assess the assay's performance compared to standard surveillance methods.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with elevated risk factors for pancreatic cancer, such as intraductal papillary mucinous neoplasms or a family history of the disease.
Not a fit: Patients with active cancer (other than pancreatic cancer) or those undergoing treatment for another active cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of pancreatic cancer, improving treatment outcomes for patients.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for cancer detection, but this specific approach with the ExoVerita™ assay is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Diego, California
- Biological Dynamics — San Diego, California, United States (RECRUITING)
Study contacts
- Principal investigator: Harmeet Dhani, MD, M.Sc — Biological Dynamics
- Study coordinator: Harmeet Dhani, MD, M.Sc
- Email: exoluminate@biologicaldynamics.com
- Phone: 858-202-6150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreas Cancer, Exosomes, Extracellular Vesicles, Pancreatic Neoplasms, Early Detection, IPMN, PDAC, Pancreatic Cancer