thyroid nodules
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients will be eligible for inclusion in the study if the following criteria are met: 1. Patient with FNAB of a thyroid nodule with a Bethesda III or IV cytopathology diagnosis 2. Patient age at the time of FNAB was 18 or older 3. No adjunctive molecular testing has been performed on the thyroid nodule 4. There are no other reasons for which surgery is planned regardless of the cytopathologial results.
Exclusion criteria
Exclusion criteria: 1. Patient has other nodule(s) in thyroid known to have diagnosis of Bethesda V or VI cytopathology, or pathological lymphnodes indicative of thyroid malignancy. 2. Surgery is already likely or planned regardless of the FNAB result due to cosmesis, rapid nodule growth, symptoms, patient request or physician recommendation 3. There are reasons for which surgery not applicable regardless of the cytopathologial results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: The primary study endpoint is the comparison of diagnostic surgical rates between the historical control group (the retrospective review of patients without GEC testing) and a prospective group in which the GEC test is added to the regular clinical management of patients with cytologically indeterminate nodules enrolled in this study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical data will be collected. | — |
Countries
Netherlands
Outcome results
None listed