Active Surveillance of Papillary Thyroid Microcarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Rate of disease progression
研究概览
简要总结
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.
详细描述
The incidence of thyroid cancer has more than doubled in the last 30 years in the United States, Europe, Canada, and South America. Since nearly 50% of this increase is attributable to papillary thyroid microcarcinomas (PTMC), it appears that greater detection and diagnosis of previously subclinical disease is a major factor driving this dramatic rise.
The primary objective is to estimate the rate of disease progression (growth of primary tumor or development of loco-regional/distant metastases) over a 3, 5, and 10-year period in a series of PTMC patients followed with active surveillance in the United States.
Patients who opt for immediate surgery can participate in a sub-study looking at quality of life and anxiety measures as compared to those patients who enroll in the active surveillance main study. Patients who enroll in active surveillance can choose to have surgery at any time that they and their treating physician feel that it is in their best interest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •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
排除标准
- •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
结局指标
主要结局
Rate of disease progression
时间窗: From time of diagnosis up to10 years of follow-up
次要结局
- Percentage of subjects that will elect surgery despite absence of clinical progression(From time of diagnosis up to 10 years of follow-up)
- Identify the clinicopathologic features associated with disease progression in papillary thyroid microcarcinoma patients followed with active surveillance(Five years)
- Quality of life score as measured by City of Hope Quality of Life Scale(Up to five years)
- Identify the genetic factors associated with an increased risk of disease progression(Five years)
- Anxiety score as measured by Memorial Anxiety Scale(Up to five years)
- Impact of TSH suppression on thyroid nodule growth (in cm) as measured by ultrasound(Five years)
研究者
Allen Ho
Director, Head and Neck Cancer Program and Co-Director, Thyroid Cancer Program
Cedars-Sinai Medical Center