EXoPERT EMERALD Clinical Study

Recruiting now

Conditions studied: Breast Cancer, Colon Cancer, Pancreatic Cancer, Ovarian Cancer, Lung Cancer

In brief

The purpose of this study is to establish a multi-center clinical repository of blood samples to support the development and evaluation of an artificial intelligence-based in vitro diagnostic software. The software analyzes surface-enhanced Raman spectroscopy (SERS) profiles of extracellular vesicles (EVs) extracted from human plasma for the early detection of multiple cancers, including lung, ovarian, breast, pancreatic, and colorectal cancers.

Key facts

Study ID

NCT07186296

Run by

EXoPERT

People needed

1400

Starts

2025-05-09

Expected to finish

2026-08-31

Last updated by the study team

2026-07-01

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Tibor Rubin VA Medical Center — Long Beach, California, United States (enrolling)
• City of Hope Duarte Cancer Center — Los Angeles, California, United States (enrolling)
• University of Hawaii Cancer Center — Honolulu, Hawaii, United States (enrolling)
• Lexington VA Healthcare System — Lexington, Kentucky, United States (enrolling)
• KCTL — Louisville, Kentucky, United States (enrolling)
• John Hopkins University — Baltimore, Maryland, United States (enrolling)
• Albany Stratton VA Medical Center — Albany, New York, United States (enrolling)
• Bronx Veterans Medical Research Foundation — The Bronx, New York, United States (enrolling)
• VA Hudson Valley Healthcare System — Wappingers Falls, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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