EXoPERT EMERALD: Early Multi-cancer Study of EV's Ramen-AL Linked Diagnosis Clinical Study Protocol
EXoPERT
Summary
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.
Description
The EMERALD study is a multi-center study (Protocol No. EXPT-MC-F-2024) designed to establish a clinical plasma repository for the training and clinical evaluation of the ExoPred deep learning software The study protocol operates in three sequential phases to ensure data integrity and prevent algorithmic overfitting: Phase 1 (Algorithm Training Stage): A minimum of 500 samples are analyzed to develop the algorithm and establish the initial clinical cut-off values, followed by a database lock. Phase 2 (Algorithm Lock-Readiness Assessment): A minimum of 50 newly acquired unknown samples are e…
Eligibility
- Age range
- 45+ years
- Sex
- All