NCT02609685 Active Surveillance of Papillary Thyroid Microcarcinoma
| NCT ID | NCT02609685 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cedars-Sinai Medical Center |
| Condition | Papillary Thyroid Microcarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 216 participants |
| Start Date | 2016-05-13 |
| Primary Completion | 2030-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The purpose of this study is to better understand the outcomes of active surveillance (observation) instead of immediate surgery, which is the current standard of care for papillary thyroid microcarcinoma (PTMC). Patients with a 1.5 cm or smaller thyroid nodule(s) with papillary thyroid carcinoma will be eligible for the study.
Eligibility Criteria
Inclusion Criteria: * Pathologically confirmed Bethesda V or VI thyroid nodules with papillary thyroid carcinoma or high clinical suspicion, or pathologically confirmed Bethesda III or IV nodules with BRAF mutation. * 2.0 cm or smaller nodules by ultrasonographic criteria * Ability to understand and the willingness to sign a written informed consent and HIPAA Authorization form * Must be able to read and write English fluently to participate in the questionnaire portion of the study Exclusion Criteria: * High-grade or poorly differentiated PTC variants * Central or lateral neck lymphadenopathy suspicious for PTC * Unfavorable nodule location (e.g. Near dorsal surface (by recurrent laryngeal nerve); Adjacent to trachea (risk of cartilage invasion) * History of radiation to neck