EXoPERT EMERALD: a blood test using AI on extracellular vesicles to detect early lung, breast, colorectal, pancreatic, and ovarian cancers.
EXoPERT EMERALD: Early Multi-cancer Study of EV's Ramen-AL Linked Diagnosis Clinical Study Protocol
This test tries to detect early lung, breast, colorectal, pancreatic, and ovarian cancers from a single blood sample by using AI to read Raman spectroscopy patterns of tiny particles called extracellular vesicles.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1400 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | EXoPERT Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 9 sites (Long Beach, California and 8 other locations) |
| Trial ID | NCT07186296 on ClinicalTrials.gov |
What this trial studies
The EXoPERT EMERALD project tests an in vitro diagnostic system that analyzes extracellular vesicles (EVs) extracted from patient plasma using surface-enhanced Raman spectroscopy (SERS) and a deep-learning algorithm. Blood is collected from adults aged 45 and older with biopsy-proven or clinically suspected lung, breast, colorectal, pancreatic, or ovarian cancer before any systemic or definitive cancer therapy, and SERS spectral profiles of EVs are used to search for cancer signatures and possible tissue-of-origin. The device can report presence of cancer and one or more tissue-of-origin predictions based on the AI interpretation of the Raman spectra. This is an observational, non-therapeutic protocol with standard exclusions for recent other cancers, recent cancer treatments, transplants, and pregnancy or breastfeeding.
Who should consider this trial
Good fit: Ideal candidates are adults 45 years or older with biopsy-proven or clinically suspected primary lung, breast, colorectal, pancreatic, or ovarian cancer who can provide a pre-treatment blood sample and give informed consent.
Not a fit: Patients with a cancer diagnosis or treatment within the past 5 years, recent surgery/chemotherapy/radiation within 6 months, prior bone marrow or solid-organ transplants, pregnant or breastfeeding individuals, or those who cannot provide pre-treatment blood are unlikely to benefit.
Why it matters
Potential benefit: If successful, the test could provide an earlier, noninvasive way to detect multiple cancer types and help identify the likely tissue of origin, potentially speeding diagnostic workup and treatment decisions.
How similar studies have performed: Early pilot studies and preclinical research using EV-based Raman spectroscopy combined with AI have shown promising signals, but large-scale clinical validation across multiple cancers is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject aged 45 years or older with a biopsy-proven or clinically suspected primary lung, breast, colorectal, pancreatic, or ovarian cancer, based on objective findings such as radiological, serological, endoscopic, or cytological findings, whose blood was collected prior to any systemic or definitive therapy for the cancer. * Subjects who are willing and able to provide written informed consent. * Subjects who are willing and able to comply with the study requirements. Exclusion Criteria: * Any history of cancer diagnosed and treated within 5 years prior to the date of consent. * Subjects with a history of previous cancer treatment via surgical resection, hormonal cancer treatment, chemotherapy, radiotherapy within the past 6 months for recent cancer diagnosis. * Subjects who have any history of an allogeneic bone marrow, stem cell transplant, or solid organ transplant. * Subjects who are pregnant or breastfeeding women. * Subjects who have consented and have undergone treatment in any other cancer related clinical trials withinthe past 6 months. * Subjects who are currently in active treatment for drug abuse. * Subjects who have received any treatment related to lung, breast, colorectal, pancreatic, or ovarian nodules, such as hormones prior to entering the study. * Unsuitable sample for testing due to contamination, hemolysis, etc.
Where this trial is running
Long Beach, California and 8 other locations
- Tibor Rubin VA Medical Center — Long Beach, California, United States (Recruiting)
- City of Hope Duarte Cancer Center — Los Angeles, California, United States (Recruiting)
- University of Hawaii Cancer Center — Honolulu, Hawaii, United States (Not_yet_recruiting)
- Lexington VA Healthcare System — Lexington, Kentucky, United States (Recruiting)
- Kctl — Louisville, Kentucky, United States (Recruiting)
- John Hopkins University — Baltimore, Maryland, United States (Active_not_recruiting)
- Albany Stratton VA Medical Center — Albany, New York, United States (Recruiting)
- Bronx Veterans Medical Research Foundation — The Bronx, New York, United States (Not_yet_recruiting)
- VA Hudson Valley Healthcare System — Wappingers Falls, New York, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Jonathan Dudley, MD — Johns Hopkins University
- Study coordinator: Young Park
- Email: paark76@korea.ac.kr
- Phone: (+82) 02 923 8833
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.