Radiofrequency Ablation for Management of Benign/Indeterminate Thyroid Nodules and Low Risk Papillary Thyroid Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Health- related Quality of Life Questionnaires
研究概览
简要总结
To track the outcomes of patients who have been treated with RFA and its long-term effectiveness, and to learn more about the quality of life of patients who have received RFA in this study.
详细描述
Primary Objectives
• To evaluate thyroid nodule volume changes over time in participants undergoing RFA as part of clinical care
Secondary Objectives
- To establish the health-related quality of life among participants undergoing with ultrasound guided RFA.
- To evaluate the sonographic features of thyroid nodules over time following ultrasound guided RFA.
- To assess adverse events rates following ultrasound guided RFA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria
- •Participants scheduled to undergo ultrasound-guided RFA for the following conditions: benign thyroid nodules, indeterminate thyroid nodules, low-risk DTC, and recurrent PTC
- •Participant is over 18 years and is either not a surgical candidate or has declined surgery.
- •Capable and willing to provide written informed consent
- •Participant has one of the following diagnoses:
- •Biopsy-proven benign thyroid nodules causing compressive and/or cosmetic symptoms who are requesting treatment,
- •Biopsy-proven indeterminate nodules (AUS or follicular neoplasm)
- •Papillary thyroid carcinoma (PTC) without metastasis
- •Locally recurrent thyroid cancer (< 2 cm).
排除标准
- •Participants meeting any of the following criteria will be excluded:
- •Participants considered unsuitable for RFA by the treating physician
结局指标
主要结局
Health- related Quality of Life Questionnaires
时间窗: Through study completion; an average of 1 year
This questionnaire includes twenty-four questions covering patients complaints ranging from 0 to 4. Patients will be asked about the presence and severity of each item currently on the medical appointment.
Health- related Quality of Life Questionnaires
时间窗: Through study completion; an average of 1 year
This questionnaire includes twenty-four questions covering patients complaints ranging from 0 to 4. Patients will be asked about the presence and severity of each item currently on the medical appointment.
次要结局
未报告次要终点