甲状腺乳头状微小癌的主动监测 (PMCAS)
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Allen Ho, MD
- 电话号码：310-423-1220
- 邮箱：Allen.Ho@cshs.org
研究联系人备份
- 姓名：Clinical Trials Navigator
- 邮箱：GroupCancerTrialInformation@cshs.org
学习地点
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-
California
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Los Angeles、California、美国、90048
- 招聘中
- Cedars-Sinai Medical Center
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接触：
- Allen Ho, MD
- 电话号码：310-423-1220
- 邮箱：Allen.Ho@cshs.org
-
首席研究员：
- Allen Ho, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Active Surveillance
Active surveillance instead of standard of care immediate surgery. Patients will be closely monitored every six months until disease is stable for a two-year period and then annually thereafter. |
Subjects will be actively observed for disease progression (condition worsens) instead of receiving immediate surgery, considered standard of care. |
|
无干预：Immediate Surgery
Patients who choose to get surgery immediately after diagnosis may choose to enroll in a questionnaire sub-study that will compare quality of life and anxiety scores to patients who enroll in the active surveillance study. This is considered "no intervention" because the protocol is not directing treatment. Surgery is the standard treatment for papillary thyroid microcarcinoma. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
疾病进展率
大体时间：从诊断到长达 10 年的随访
|
从诊断到长达 10 年的随访
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
尽管没有临床进展但仍选择手术的受试者百分比
大体时间：从诊断到随访 10 年
|
从诊断到随访 10 年
|
|
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TSH 抑制对超声测量的甲状腺结节生长的影响（以厘米为单位）
大体时间：5年
|
5年
|
|
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确定与主动监测的乳头状甲状腺微小癌患者疾病进展相关的临床病理学特征
大体时间：5年
|
5年
|
|
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通过希望之城生活质量量表衡量的生活质量分数
大体时间：长达五年
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长达五年
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|
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通过纪念焦虑量表测量的焦虑评分
大体时间：长达五年
|
长达五年
|
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Identify the genetic factors associated with an increased risk of disease progression
大体时间：Five years
|
At any time subjects who have enrolled in the active surveillance study can opt to have surgery. Data will be taken from diagnosis to just after surgery. |
Five years
|
合作者和调查者
调查人员
- 首席研究员：Allen Ho, MD、Cedars-Sinal Medical Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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