Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Center, Korea
About this trial
This study is a multicenter cluster-randomized controlled trial conducted in Korea. A parallel, two-group cluster-randomized design will be used to test whether the Shared decision-making Group (SDM; intervention) is different from the Standard Care Group (SC; control).
Eligibility criteria
Qualifiers
Adults aged 18 years or older with a thyroid nodule of 1.0 cm or less confirmed as Bethesda category V (suspicious for PTC) or VI (PTC) based on cytopathological examination, or Bethesda category III (atypia of undetermined significance) with a confirmed BRAF V600E mutation.
Patients with no evidence of distant metastasis, cervical lymph node metastasis, recurrent laryngeal nerve invasion, or tracheal invasion. Additionally, no evidence of extrathyroidal extension (ETE) should be present, and the tumor must not belong to high-risk subtypes of PTC (e.g., diffuse sclerosing, columnar cell, or solid subtype).
Disqualifiers
Patients who cannot undergo regular follow-up or are expected to have difficulties with follow-up.
Patients with indeterminate or benign findings on thyroid biopsy.
Trial design
Treatments tested in this trial
- SDM protocol
Treatment groups
310 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
National Cancer Center, Korea
Lead sponsor
Seoul National University Hospital
Collaborator
Seoul National University Bundang Hospital
Collaborator
SMG-SNU Boramae Medical Center
Collaborator
Nowon Eulji Medical Center
Collaborator
Hanyang University
Collaborator
Source ClinicalTrials.gov