Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT03905369
Eligibility Criteria:
Decision 1: total thyroidectomy vs. hemithyroidectomy:
Inclusion Criteria:
* patients with nodules \>1 cm and \<4 cm, with cytology result suspicious or malignant (Bethesda 5 or 6) with no clinical or radiological evidence of pathological lymph nodes and/or distant metastases before the primary (diagnostic) surgery
* patients with histologically (after diagnostic hemithyroidectomy) proven TC but are defined as low-risk according to the ATA classification.
Exclusion criteria:
* patients with multifocal TC
* patients with incomplete resection of the primary tumor
* patients with ATA defined intermediate risk or high risk
Decision 2: no treatment with RAI vs. treatment with RAI:
Inclusion criteria:
• patients with ATA defined low-risk and patients with multifocal papillary TC in the absence of other adverse features
Exclusion criteria:
• patients with ATA defined intermediate and high risk
Decision 3: active surveillance vs. systemic treatment
Inclusion criteria:
• patients with asymptomatic or mildly symptomatic RAI-refractory (slowly) progressive metastatic disease
Exclusion criteria:
• patients with coexisting conditions that do not allow prescription of TKI's
Other exclusion Criteria:
* lack of Dutch language proficiency
* mental incompetence hampering the process of shared decision making as judged by the physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03905369
Study Brief:
Protocol Section:
NCT03905369