Retrospective-Prospective Collection of Thyroid Specimens After FNA
概览
- 阶段
- 不适用
- 干预措施
- Diagnostic DNA Methylation Signature
- 疾病 / 适应症
- Thyroid Gland Nodule
- 发起方
- City of Hope Medical Center
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Sensitivity of the diagnostic deoxyribonucleic acid (DNA) methylation signature (DDMS)
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
This trial studies how well the diagnostic deoxyribonucleic acid (DNA) methylation signature works in detecting thyroid cancer in patients with thyroid nodules. Using diagnostic testing, such as the diagnostic DNA methylation signature, may be a less invasive way to check for thyroid cancer.
详细描述
PRIMARY OBJECTIVES: I. To validate a novel epigenetic thyroid nodule diagnostic test, diagnostic DNA methylation signature (DDMS) in a retrospective-prospective study with leftover of fine needle aspiration biopsies. OUTLINE: Previously collected FNA aspiration specimen samples are analyzed via DDMS assay. Participants undergo FNA aspiration for collection of tissue samples for analysis via DDMS assay. After completion of study, patients are followed up yearly for 5 years.
研究者
入排标准
入选标准
- •All patients undergoing FNA for thyroid nodule diagnosis.
- •Any race and ethnicity are eligible for the study.
- •Patient should have thyroid nodule(s) with indeterminate diagnosis after FNA (Bethesda category of indeterminate FNA \[III-V\]).
排除标准
- 未提供
研究组 & 干预措施
Diagnostic (biospecimen collection)
Previously collected FNA aspiration specimen samples are analyzed via DDMS assay. Participants undergo FNA aspiration for collection of tissue samples for analysis via DDMS assay.
干预措施: Diagnostic DNA Methylation Signature
结局指标
主要结局
Sensitivity of the diagnostic deoxyribonucleic acid (DNA) methylation signature (DDMS)
时间窗: Up to 5 years
Will be assessed by taking the ratio of the number of thyroid cancer specimens diagnosed as cancer using the DDMS and the total number of thyroid cancer specimens according to the final diagnosis. Will determine the 95% confidence intervals.
Specificity of DDMS
时间窗: Up to 5 years
Will be assessed by taking the ratio of the number of benign nodules diagnosed by DDMS and the total number of benign thyroid nodule specimens according to the final diagnosis. Will determine the 95% confidence intervals.
Positive predictive value (PPV)
时间窗: Up to 5 years
Will calculate PPV by dividing the number of true thyroid cancer specimens by the number of thyroid cancer diagnosis by DDMS. Will determine the 95% confidence intervals.
Negative predictive value (NPV)
时间窗: Up to 5 years
Will calculate NPV by dividing the number of benign nodules by the number of benign diagnosis by DDMS. Will determine the 95% confidence intervals.