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

• Conditions: Papillary thyroid carcinoma; Thyroid cancer; 10043739; 10014713; 10014705

• Registration Number: NL-OMON55252
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 12

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 well differentiated (classic or follicular variant) 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

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Positive resection margins or extensive extrathyroidal extension as defined
for in the 8th edition of the AJCC/TNM classification of thyroid cancer for
extension of a T3 tumor upon histology or ultrasound.
- Lymph node involvement confirmed by ultrasound and FNA prior to randomization
- Multifocality
- Vascular invasion
- Aggressive histology (e.g. poorly differentiated, tall cell, columnar cell,
hobnail variant, diffuse sclerosing variant PTC)
- Certain classification of NIFTP on histology
- 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
<p>Primary study outcome<br /><br>Primary endpoint consists of the participation of patients eligible for the<br /><br>study</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes<br /><br>1. Time needed to include 12 patients<br /><br>2. Reasons for patients to deny participation<br /><br>3. Total number of patients and percentage of patients in the active<br /><br>surveillance group who wish to be treated according to the current guidelines<br /><br>4. Quality of life outcomes as assessed by EQ5D5L, SF-36, ThyPro39 and the Fear<br /><br>of Cancer Recurrence questionnaires.<br /><br>5. Logistical hurdles </p><br>