De-escalation of treatment for Papillary Thyroid Cancer followed by Active Surveillance – a pilot study

o sponsors0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•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
•o Cytologically proven Bethesda 6
•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

•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

发起方

o sponsors