EXoPERT EMERALD: Early Multi-cancer Study of EV's Ramen-AL Linked Diagnosis Clinical Study Protocol
EXoPERT
Summary
Invitro diagnostic test for multiple cancer diagnosis for patients with early-stage cancers by analyzing surface-enhanced Ramen spectroscopy (SERS) profiles of extracellular vesicles (EV) using artificial intelligence.
Description
An in vitro diagnostic medical device and system that provides information on the presence of lung, ovarian, breast, pancreas and colorectal cancers based on a deep learning analysis for Raman spectroscopic profiles of EV's extracted from human plasma. Tissue of origin (TOO) can be presented as one or more.
Eligibility
- Age range
- 45+ years
- Sex
- All
- Healthy volunteers
- Yes
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 o…
Interventions
- Diagnostic TestEXoPred
Performing invitro Diagnostics with devices developed by EXoPERT.
Locations (9)
- Tibor Rubin VA Medical CenterLong Beach, California
- City of Hope Duarte Cancer CenterLos Angeles, California
- University of Hawaii Cancer CenterHonolulu, Hawaii
- Lexington VA Healthcare SystemLexington, Kentucky
- KCTLLouisville, Kentucky
- John Hopkins UniversityBaltimore, Maryland