Isolation and Characterization of Extracellular Vesicles in Patients With Thyroid Nodules and Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Positive predictive value of molecular profile of thyroid-derived extracellular vesicles
研究概览
简要总结
This study is being done to help researchers learn more about and successfully diagnose cancer using blood samples and tissue samples from surgeries in patients with suspicious thyroid nodules or thyroid cancer. Diagnosing cancer in this way, as opposed to biopsies, may be less invasive to the patient. Analyzing blood and tissues samples may also help researchers to differentiate non-cancerous tumors from thyroid cancer and detect high-risk mutations to guide treatment.
详细描述
PRIMARY OBJECTIVE:
I. Sensitivity and specificity of molecular profile of thyroid derived extracellular vesicles (EVs) as predictor of thyroid cancer.
SECONDARY OBJECTIVES:
I. Quantity of thyroid derived EVs captured in various stages of thyroid cancer.
II. Whether quantity of EVs decreases in proportion to response to therapy in thyroid cancer patients.
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
- •Aged 18 and older
- •Consented for thyroid surgery for thyroid cancer or indeterminate thyroid nodule
排除标准
- •Patients with concurrent malignancy
研究组 & 干预措施
Ancillary-correlative (biospecimen collection)
Patients undergo collection of blood samples on the day of surgery following anesthesia but prior to incision and at the first routine blood test following surgery. Patients who undergo remnant ablation after total thyroidectomy with radioactive iodine have an additional blood sample collected. Patients also undergo collection of tissue samples following surgical resection of thyroid nodule or thyroid cancer. Patients' medical records are also reviewed.
干预措施: Biospecimen Collection (Procedure)
Ancillary-correlative (biospecimen collection)
Patients undergo collection of blood samples on the day of surgery following anesthesia but prior to incision and at the first routine blood test following surgery. Patients who undergo remnant ablation after total thyroidectomy with radioactive iodine have an additional blood sample collected. Patients also undergo collection of tissue samples following surgical resection of thyroid nodule or thyroid cancer. Patients' medical records are also reviewed.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Positive predictive value of molecular profile of thyroid-derived extracellular vesicles
时间窗: Up to 3 years
Specificity of molecular profile of thyroid-derived extracellular vesicles
时间窗: Up to 3 years
Sensitivity of molecular profile of thyroid-derived extracellular vesicles
时间窗: Up to 3 years
Negative predictive value of molecular profile of thyroid-derived extracellular vesicles
时间窗: Up to 3 years
次要结局
- Quantity of thyroid-derived extracellular vesicles captured in patients with localized, regional, and distant disease versus benign thyroid adenomas(Up to 3 years)
- Quantity of thyroid-derived extracellular vesicles captured in patients with excellent, indeterminate, biochemically incomplete, and structural incomplete responses to initial therapy(Up to 3 years)
- Combination of ribonucleic acid/deoxyribonucleic acid-based tests that can be perf thyroid-derived extracellular vesicles(Up to 3 years)