EXoPERT EMERALD: Early Multi-cancer Study of EV's Ramen-AL Linked Diagnosis Clinical Study Protocol
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.
Detailed 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.
Arms & interventions
- Diagnostic TestEXoPred
Performing invitro Diagnostics with devices developed by EXoPERT.
Outcome measures
Primary
Test Sufficient Samples
Test sufficient samples from 5 cancers to lock an validate algorithm to support future clinical study.
Time frame: From date of enrollment up to 36 months
Evaluate Performance
Test performance: diagnosis of multiple cancer, assessed by sensitivity. Test performance: diagnosis of multiple cancer, assessed by specificity. Test performance: diagnosis of multiple cancer, assessed by tissue of origin (TOO) accuracy.
Time frame: From date of enrollment up to 36 months
Eligibility criteria
Study locations (9)
Tibor Rubin VA Medical Center
Long Beach, California, 90822
City of Hope Duarte Cancer Center
Los Angeles, California, 91010
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
Lexington VA Healthcare System
Lexington, Kentucky, 40502
KCTL
Louisville, Kentucky, 40202
John Hopkins University
Baltimore, Maryland, 21218
Albany Stratton VA Medical Center
Albany, New York, 12208
Bronx Veterans Medical Research Foundation
The Bronx, New York, 10468
VA Hudson Valley Healthcare System
Wappingers Falls, New York, 12590