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A Prospective Validation Study of a Risk Prediction Model for Thyroid Dysfunction Related to Immune Checkpoint Inhibitors

A Prospective Validation Study of a Risk Prediction Model for Thyroid Dysfunction Related to Immune Checkpoint Inhibitors

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128236
Enrollment
Unknown
Registered
2026-07-16
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

immune-related thyroid dysfunction, irTD

Interventions

Intermediate-risk group:None

Sponsors

Changxing County People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime frame
Incidence of irTD;Area under the ROC curve;

Countries

China

Contacts

Public ContactFan Weibin

Changxing County People's Hospital

weibinfan@hotmail.com+86 572 626 7652

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026