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Early Warning Model for Thyroid Dysfunction Induced by Novel Anticancer Agents

Novel Antitumor Drug–Associated Thyroid Dysfunction Adverse Event Signal Mining and Risk Prediction Model Construction

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126951
Enrollment
Unknown
Registered
2026-06-20
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Hypothyroidism and Hyperthyroidism

Interventions

Gold Standard:Clinical outcomes (Complete thyroid function tests)
Index test:A risk prediction model for thyroid dysfunction adverse events associated with antineoplastic agents.

Sponsors

The First Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years at the time of initial treatment. 2. Histologically or cytologically confirmed malignancy. 3. First-ever treatment with novel antitumor agents (including but not limited to immune checkpoint inhibitors, tyrosine kinase inhibitors, and antibody–drug conjugates) at our institution between January 1, 2019 and December 31, 2025. 4. Availability of at least one thyroid function assessment (including TSH, FT3, and FT4) performed at baseline (prior to treatment initiation) and/or during the treatment period.

Exclusion criteria

Exclusion criteria: 1.Patients with a pre-existing diagnosis of thyroid dysfunction (including hyperthyroidism, hypothyroidism, and thyroiditis) prior to the initiation of novel antitumor therapy, or those receiving concurrent thyroid hormone replacement or antithyroid medication. 2. Receipt of neck radiotherapy or surgery with potential impact on thyroid function within 30 days prior to the first dose of study medication. 3. Concurrent use of non-antitumor agents known to cause thyroid dysfunction (e.g., amiodarone, interferon). 4. Incomplete key clinical data (e.g., medication administration records, follow-up information) that precluded meaningful analysis.

Design outcomes

Primary

MeasureTime frame
Complete thyroid function tests (TFTs);Independent risk factors for the development of DTD.;Signal strength of the association between novel antineoplastic agents and DTD.;

Secondary

MeasureTime frame
Area Under the Receiver Operating Characteristic Curve, AUC/ROC;Model calibration;

Countries

China

Contacts

Public ContactHui Wu

The First Affiliated Hospital of Kunming Medical University

649800315@qq.com+86 871 65324888

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026