EXoPERT EMERALD: a blood test using AI on extracellular vesicles to detect early lung, breast, colorectal, pancreatic, and ovarian cancers.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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 Recruiting
• Lexington VA Healthcare System
  Lexington, Kentucky, United States Recruiting
• Kctl
  Louisville, Kentucky, United States Recruiting
• John Hopkins University
  Baltimore, Maryland, United States 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.