Active Surveillance, Thyroid Cancer
Conditions
Brief summary
Patients with a single, small (less than 2 cm) cancer nodule in the thyroid gland will be offered active surveillance initially for 5 years. In case of cancer growth or changes in ultrasonographic appearance, further treatment will be offered.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* age of 30 years or older AND * single, well-defined tumor in the thyroid gland, with a FNAB suspicious of cancer or diagnostic of cancer (category V or VI in the Bethesda system) AND * tumor size of 2 cm or less in all dimensions.
Exclusion criteria
* suspicion of disseminated disease because of: * PET-positive lymph nodes on the neck * suspicious lymph-nodes by neck ultrasonography (US) * signs of capsular invasion of the tumor * suspicion of metastatic disease due to findings on PET-CT-scan or thoracic CT-scan; OR * tumor placement at a high-risk location (in the thyroid capsule or near the trachea) OR * previous thyroid surgery OR * concomitant hyperparathyroidism (ionized calcium \> 1.32 mmol/L and PTH \> 6 pmol/L) OR * if the patient is pregnant OR * If the patient is unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment | 24 months | The need for treatment due to tumor growth within 24 months (cumulative incidence) |
Countries
Denmark