Evaluation of DNA Methylation Signatures in Diagnosis and Management of Thyroid Nodules
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,450
- 试验地点
- 1
- 主要终点
- Positive predictive value (PPV) of DDMS-2
研究概览
简要总结
This clinical trial evaluates deoxyribonucleic acid (DNA) methylation signatures in diagnosing and managing thyroid nodules. The purpose of this research is to develop a new test for thyroid cancer. This test will use needle biopsies (small collections of tissue with a needle) from the thyroid to determine whether the participant has a malignant (cancer) or benign (not showing cancer) thyroid tumor. The information learned from this trial may help develop a more accurate test so that patients do not have unnecessary surgeries for nodules that are thought to be suspicious but are actually benign.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the effect of Diagnostic DNA Methylation Signatures (DDMS-2) results (positive predictive value [PPV], negative predictive value [NPV], sensitivity and specificity) on physician decision-making for clinical management of 800 indeterminate thyroid nodules.
SECONDARY OBJECTIVES:
I. To determine sensitivity and specificity, PPV, NPV of DDMS-2 with 1450 needle biopsies including 800 needle biopsies with indeterminate cytopathology.
II. Compare the diagnostic accuracy between DDMS-2 and two currently used diagnostic approaches based on genetic alterations and gene expression within the same prospective cohort of 800 indeterminate needle biopsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients without impaired decision-making capacity and who are undergoing needle biopsies for thyroid nodule diagnosis
- •Over the age of 18
- •Any gender, race and ethnicity
- •Patients must provide informed consent prior to use of their tissues and clinical data
排除标准
- •Children are excluded from the study, since the biology of children thyroid nodules is different from adults
研究组 & 干预措施
Diagnostic (needle biopsy, DDMS-2)
Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.
干预措施: Diagnostic Procedure (Procedure)
Diagnostic (needle biopsy, DDMS-2)
Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.
干预措施: Electronic Health Record Review (Other)
Diagnostic (needle biopsy, DDMS-2)
Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.
干预措施: Needle Biopsy (Procedure)
结局指标
主要结局
Positive predictive value (PPV) of DDMS-2
时间窗: Up to 5 years
PPV (number of true thyroid cancer specimens by DDMS / number of thyroid cancers diagnosis by DDMS) will be calculated. Will also determine the 95% confidence intervals.
Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2)
时间窗: Up to 5 years
The sensitivity of DDMS-2 will be estimated by taking the ratio of the number of true thyroid cancer specimens diagnosed as cancer by DDMS and the total number of thyroid cancer specimens. Will also determine the 95% confidence intervals.
Specificity of DDMS-2
时间窗: Up to 5 years
The specificity will be estimated by taking the ratio of the number of true benign nodules diagnosed as benign by DDMS and the total number of true benign thyroid nodules. Will also determine the 95% confidence intervals.
Negative predictive value (NPV) of DDMS-2
时间窗: Up to 5 years
NPV (number of true benign nodules diagnosed by DDMS/number of benign diagnosis by DDMS) will be calculated. Will also determine the 95% confidence intervals.
次要结局
未报告次要终点