ctDNA in Patients With Thyroid Nodules
2017年8月16日 更新者：Pathway Genomics
Determination of the Utility of Plasma Circulating Tumor DNA (ctDNA) Measurements for Detection of Thyroid Cancer in Patients Undergoing Diagnostic Fine Needle Aspirations of the Thyroid
When the DNA inside of human cells undergoes certain alterations (mutations), the cells may develop into a cancer.
The cancer cells may shed this DNA into the blood stream.
This circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory tests.
Measurement of ctDNA has been shown to be useful for following patients with known cancer.
The purpose of this study is to examine blood specimens for the presence of ctDNA in individuals without known cancer who are scheduled to undergo a fine needle aspiration biopsy of the thyroid gland because of one or more thyroid nodules in order to see if the ctDNA test can detect a cancer at a very early stage.
The results of this study should help define the role of ctDNA in the detection of early stage thyroid cancer and to define how sensitive it is (i.e.
how well it picks up cancer when it is present) and how specific it is (i.e.
how often is ctDNA found in patients with benign thyroid nodules).
研究概览
详细说明
After the participants with thyroid nodules or other abnormalities have undergone the informed consent process, they will have 30 milliliters (approximately two tablespoons) of blood drawn.
This will be done prior to the performance of the fine needle aspiration biopsy of the thyroid.
If the patient has indicated a desire to receive the results of their test, they will receive a written description, as will their physician.
The patients will be contacted yearly for up to 5 years by the study staff to learn whether they have been found to have a diagnosis of thyroid or other cancer.
研究类型
观察性的
注册 (实际的)
66
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Florida
-
Sarasota、Florida、美国、34239
- Thyroid & Endocrine Center of Florida
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Individuals 18 year of age or older without a prior diagnosis of cancer who are going to undergo a fine needle aspiration biopsy of the thyroid gland as part of their standard care.
描述
Inclusion Criteria:
- 18 years of age or older;
- presence of one or more thyroid nodules who are going to have a fine needle aspiration biopsy performed as part of their normal care.
Exclusion Criteria:
- Prior history of cancer excluding basal cell carcinoma of the skin.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Utility of plasma ctDNA measurements to detect thyroid cancer
大体时间：1 year
|
Correlation between plasma ctDNA results with pathology from the diagnostic fine needle aspiration biopsy of the thyroid gland.
|
1 year
|
|
Screening characteristics of ctDNA measurement in patients with and without thyroid cancer.
大体时间：1 year
|
Determination of true positive, false positive and predictive values for using ctDNA measurements to detect thyroid cancer.
|
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Determination of incident rate of new thyroid or other cancers in patients who underwent initial measurement of ctDNA.
大体时间：5 years
|
Subjects will be contacted yearly to obtain follow-up information regarding the development of thyroid or other cancer in order to see if the initial ctDNA measurement detected the cancer before it became clinically apparent.
|
5 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Glenn D. Braunstein, M.D.、Pathway Genomics
- 首席研究员：Anja Kammesheidt, PhD、Pathway Genomics
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年5月1日
初级完成 (实际的)
2017年8月1日
研究完成 (实际的)
2017年8月1日
研究注册日期
首次提交
2016年5月16日
首先提交符合 QC 标准的
2016年5月17日
首次发布 (估计)
2016年5月19日
研究记录更新
最后更新发布 (实际的)
2017年8月21日
上次提交的符合 QC 标准的更新
2017年8月16日
最后验证
2017年8月1日
更多信息
与本研究相关的术语
其他研究编号
- Pathway Genomics-007
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The patient's physician will receive the results and the patients have the option to also receive the results.
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.