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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Utility of plasma ctDNA measurements to detect thyroid cancer
研究概览
简要总结
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).
详细描述
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
- •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.
排除标准
- •Prior history of cancer excluding basal cell carcinoma of the skin.
结局指标
主要结局
Utility of plasma ctDNA measurements to detect thyroid cancer
时间窗: 1 year
Correlation between plasma ctDNA results with pathology from the diagnostic fine needle aspiration biopsy of the thyroid gland.
Screening characteristics of ctDNA measurement in patients with and without thyroid cancer.
时间窗: 1 year
Determination of true positive, false positive and predictive values for using ctDNA measurements to detect thyroid cancer.
次要结局
- Determination of incident rate of new thyroid or other cancers in patients who underwent initial measurement of ctDNA.(5 years)