Potential biomarkers for postcurative monitoring
| Therapeutic monitoring laboratory biomarkers . | SCT or GT/E . | Direct or surrogate biomarker . | Biomarker value validation . |
|---|---|---|---|
| Change in deep tissue oxygenation steady state* (SpO2, pCO2, pO2; bicarbonate, lactate; VO2; VCO2) | SCT/GT/E | Surrogate/direct | Research gap |
| Steady-state ischemia/reperfusion* (TNF, NF-κB, IL-β1; WBC adhesion) | SCT/GT/E | Surrogate/direct | Research gap |
| Change in endothelial activation* (P-selectin expression) | SCT/GT/E | Surrogate/direct | Research gap |
| Change in proteomics/epigenetics/metabolomics* | SCT/GT/E | Surrogate/direct | Research gap |
| Therapeutic monitoring laboratory biomarkers . | SCT or GT/E . | Direct or surrogate biomarker . | Biomarker value validation . |
|---|---|---|---|
| Change in deep tissue oxygenation steady state* (SpO2, pCO2, pO2; bicarbonate, lactate; VO2; VCO2) | SCT/GT/E | Surrogate/direct | Research gap |
| Steady-state ischemia/reperfusion* (TNF, NF-κB, IL-β1; WBC adhesion) | SCT/GT/E | Surrogate/direct | Research gap |
| Change in endothelial activation* (P-selectin expression) | SCT/GT/E | Surrogate/direct | Research gap |
| Change in proteomics/epigenetics/metabolomics* | SCT/GT/E | Surrogate/direct | Research gap |
IL, interleukin; TNF, tumor necrosis factor.
Potential biomarkers that meet the FDA guidance for rare disease trial end points (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613026.htm).