Papillary Thyroid Cancer 1-4 cm
Conditions
Interventions
hemithyroidectomy and active surveillance. Standard treatment
total thyroidectomy with RAI.
Sponsors
No sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Able to undergo surgery - Age of 18 years and older - Diagnosed with unilateral papillary thyroid cancer with a diameter of 1-4 cm, as defined by: o Histologically proven PTC after diagnostic hemithyroidectomy 1-4cm or o Cytologically proven Bethesda 6 or o Cytologically proven Bethesda 5 nodule with confirmed BRAF mutation - Size of index nodule / tumor must be between 1 and 4cm, measured by ultrasound or on histopathology. Histopathology may overrule ultrasound measurements. - Ultrasound of the neck excluding lymph node involvement - Signed informed consent by patient
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Extrathyroidal extension upon definitive histology or ultrasound examination - Lymph node involvement confirmed by ultrasound and FNA prior to randomization - Multifocality - Aggressive histology (e.g. tall cell, columnar cell) - A contralateral nodule requiring intervention (if applicable) - Pregnant women - Insufficient understanding of the Dutch language to understand the study documents - Minors (age < 18 years) and incapacitated subjects do not meet the eligibility criteria and will therefore not be enrolled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint consists of the participation of patients eligible for the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes 1. Time needed to include 12 patients 2. Reasons for patients to deny participation 3. Total number of patients and percentage of patients in the active surveillance group who wish to be treated according to the current guidelines 4. Quality of life outcomes as assessed by EQ5D5L, SF-36, ThyPro39 and the Fear of Cancer Recurrence questionnaires. 5. Logistical hurdles | — |
Contacts
Public ContactSam van Dijk
Erasmus MC
Outcome results
None listed