Dutch De-escalation pilot Study
- Conditions
- Papillary Thyroid Cancer 1-4 cm
- Registration Number
- NL-OMON22164
- Lead Sponsor
- o sponsors
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint consists of the participation of patients eligible for the study.
- Secondary Outcome Measures
Name Time Method Secondary outcomes<br>1. Time needed to include 12 patients<br>2. Reasons for patients to deny participation<br>3. Total number of patients and percentage of patients in the active surveillance group who wish to be treated according to the current guidelines<br>4. Quality of life outcomes as assessed by EQ5D5L, SF-36, ThyPro39 and the Fear of Cancer Recurrence questionnaires.<br>5. Logistical hurdles