immune-related thyroid dysfunction, irTD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age =18 years, either sex; 2.Histopathologically confirmed solid malignancy; 3.Planned treatment with PD-1/PD-L1 inhibitor monotherapy or combination therapy (first-line or regimen change); 4.ECOG performance status 0–2; 5.Expected survival =6 months; 6.Able to understand the study content and provide written informed consent;
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed thyroid dysfunction (hyperthyroidism, hypothyroidism, thyroiditis) that is not under control; 2. Having other autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, etc.); 3. Currently using glucocorticoids (> 10 mg/day prednisone equivalent) or immunosuppressants; 4. Pregnant or breastfeeding women; 5. Having severe heart, liver, or kidney dysfunction (Child-Pugh class C or eGFR < 30 ml/min); 6. Other situations that the researcher thinks are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of irTD;Area under the ROC curve; | — |
Countries
China
Contacts
Changxing County People's Hospital