Thyroid Cancer
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Thyroid nodule requiring additional diagnostic follow-up (TI-RADS/Bethesda) - Patients with thyroid problems requiring surgery (e.g. goiter) - Breath collection before undergoing cytological puncture or at least 3 days after cytological puncture pre-operatively. - > 18 year. - Signed informed consent,
Exclusion criteria
Exclusion criteria: - Other underlying malignancy, (less than 5 years ago), basal cell carcinoma not included - Unable to participate due to comorbidities (e.g. COPD) - Not understanding the information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary parameters of diagnostic accuracy will be sensitivity, positivity, and ROC-AUC (Area Under the Curve of the Receiver Operating Characteristics curve) of the GC-IMS model for detecting thyroid malignancy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: A database will be maintained with patient characteristics, quality of life and emotional burden questionnaires, and surgical complications (hypoparathyroidism, bleeding, wound infection, damage to the vocal cord nerve, duration of the hospital stay) with accompanying clavien-dindo classification. The number of unnecessary surgeries will be evaluated. Refusing to participate in the study will be tracked to evaluate patient acceptance of the Aeonose in clinical practice. Participating patients will assess the convenience of using the Aeonose by means of a VAS scale. Sensitivity and specificity of molecular diagnostics (BRAF mutation) on the cytology of thyroid punctures, urine and blood after regular blood sampling will be evaluated. Tissue obtained from the patients will be examined. | — |
Countries
Netherlands
Outcome results
None listed