None
Conditions
Interventions
Observation group:None
Sponsors
Shanghai Sixth People’s Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. No age or gender restrictions; patients with osteosarcoma who have been clinically diagnosed and require treatment with methotrexate (MTX); 2. Clinical orders require MTX blood concentration monitoring (i.e., blood samples must be collected for LC or LC-MS/MS analysis); 3. The patient or their legal guardian voluntarily agrees to participate in this study and signs an informed consent form; 4. The volume of blood samples collected for routine testing is >= 5 mL (serum is separated by immediate centrifugation, ensuring that after using 1 mL of serum for LC or LC-MS/MS analysis, an additional 1 mL of serum can be reserved for SERS detection); 5. Blood samples show no quality abnormalities such as hemolysis or coagulation (as determined on-site by laboratory physicians).
Exclusion criteria
Exclusion criteria: 1. The blood samples exhibit quality issues such as hemolysis, coagulation, or contamination, rendering them unsuitable for Surface-Enhanced Raman Scattering (SERS) detection; 2. Contamination or leakage occurred during the SERS detection process, resulting in invalid detection data; 3. The results from Liquid Chromatography (LC) or LC-MS/MS are "invalid" (e.g., due to instrument malfunction or errors in sample pretreatment), making them unusable as reference standards for comparison; 4. Force majeure events (such as failure of sample storage equipment or interruption of reagent supply) prevented the completion of SERS detection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Methotrexate (MTX) blood concentration;Consistency of SERS with LC or LC–MS/MS method results; | — |
Secondary
| Measure | Time frame |
|---|---|
| Within-batch precision of the SERS method; | — |
Countries
China
Contacts
Public ContactCuixia Yang
Shanghai Sixth People’s Hospital
Outcome results
None listed