Studies on Thyroid Nodules and Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Evaluation of thyroid cancer
研究概览
简要总结
Participants in this study will be patients diagnosed with or suspected to have a thyroid nodule or thyroid cancer.
The main purpose of this study is to further understand the methods for the diagnosis and treatment of thyroid nodules and thyroid cancer. Many of the test performed are in the context of standard medical care that is offered to all patients with thyroid nodules or thyroid cancer. Other tests are performed for research purposes. In addition, blood and tissue samples will be taken for research and genetic studies.
详细描述
The purpose of this study is to gain knowledge and experience in the diagnosis and therapy of thyroid cancer using established best standard of care and new techniques and approaches as they are developed. Study subjects will include adults and children with thyroid nodules requiring diagnostic imaging and fine needle aspiration biopsy, surgery, radioiodine scanning or therapy, appropriate follow up, consisting of tumor markers monitoring and anatomical and functional imaging. The limitations and significance of serum thyroglobulin (Tg) measurement for diagnosing tumor recurrence will be assessed. The study will permit a continued evaluation of the risk/benefit ratio of already established methods of administering radioiodine therapy, including the impact of pre-treatment dosimetric calculations, individualizing treatment with radioiodine. Under this protocol, samples of benign nodules and cancer tissue specimens for research studies will be collected. Data and samples collected during routine clinical care will be used to address research questions utilizing a number of approaches including microscopy, immunohistochemistry, proteomics and molecular analysis. All research studies will relate to the diagnosis, natural history and therapy of thyroid tumors, regulation of thyroid function, and the effects of thyroid function on the body. Blood and urine specimens will be collected for research studies in both the hypothyroid and euthyroid state.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 98 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Male or female, adults or children >= 6 months+.
- •Patients with known or suspected thyroid nodules and/or thyroid cancer.
- •At risk family members of patients who have a genetic susceptibility to developing thyroid cancer.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •1. Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma requiring intervention before thyroid cancer is addressed.
研究组 & 干预措施
thyroid nodules
Patients with thyroid nodules
干预措施: 68-Gallium Dotatate (Drug)
thyroid cancer
Patients with thyroid cancer
干预措施: 68-Gallium Dotatate (Drug)
结局指标
主要结局
Evaluation of thyroid cancer
时间窗: As clinically indicated
Blood draws, CT and other scans, physical exams, surgery (if applicable), thyroid biopsy (if applicable).
Evaluation of thyroid disorders
时间窗: As clinically indicated
blood draws, CT and other scans, physical exam.
次要结局
未报告次要终点
