Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma- A Multi-Center Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 10
- 主要终点
- Accurate diagnosis of suspicious cervical lymph node in the operating room being benign or malignant
研究概览
简要总结
Background: Despite a favorable prognosis, metastatic cervical lymph nodes (LN), are not uncommon among patients with differentiated thyroid cancer (DTC). Current guidelines recommend that a suspicious cervical LN on neck ultrasound (US) should be investigated with fine needle aspiration biopsy for cytology (FNAC) and for thyroglobulin (Tg) measurement (FNA-Tg), using saline washout of the needle content. Since Tg is a protein produced exclusively by thyroid follicular cells, a positive FNA-Tg result establishes the diagnosis of metastatic DTC. Currently, following LN biopsy, a patient must wait days to weeks to receive results, that directly impacts the treatment plan. This delay may be solved by a point of care assay of the washout Tg (POC-Tg), drawn from a suspicious cervical LN. Another potential novel usage of POC-Tg is the evaluation of suspicious LN found during neck surgery for known or suspicious DTC. Here, the POC-Tg may save the time needed for the completion of 'frozen section'.
The study product: POC-Tg is a lateral flow immunoassay for Tg, able to detect within minutes Tg at concentration equal to 5 ng/mL and above (the midrange of the accepted cut-off).
Methods: The multi-center validation study will include 100 patients in the FNA clinic, and 150 LN (dissected from 50-150 patients) in the operating room (OR). Each LN will be evaluated using both the formal accepted method (in the FNA clinic, the combination of FNAC and FNA-Tg; and frozen section in the OR), and the novel POC-Tg. Clinical decisions will be made according to the formal evaluation only. In a retrospective analysis, the investigators will estimate the sensitivity and specificity of the POC-Tg and the formal accepted method against the reference ('gold') standard (cytology, histology and follow-up US in the FNA clinic setting, and final histology in the OR setting).
详细描述
Methods and materials
Hypothesis: The diagnostic accuracy of the novel POC-Tg will be comparable with the current diagnostic methods used for the evaluation of cervical LNs suspected as DTC metastases.
Aim
- To validate the POC-Tg in the FNA clinic: Indeterminate or suspicious cervical LNs in patients with known or suspected DTC will be assessed using both the novel POC-Tg, and the formal evaluation (formal immunoassay for Tg and cytology).
- To validate the POC-Tg in the OR: Indeterminate or suspicious cervical LNs in patients operated for DTC will be assessed using both the novel POC-Tg and the formal evaluation (frozen section and/or final histology in the pathological institution).
Significance: An accurate POC-Tg may change current diagnostic and treatment approaches of patients with suspected metastatic DTC and improve patient management.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are able and agree to sign the informed consent document.
- •Aged 18 years or older.
- •In the FNA clinic arm:
- •Patients evaluated for thyroid nodule/s suspected or known as DTC, accompanied by cervical LN/s suspected as DTC metastasis.
- •Patients following treatment for DTC (partial or total thyroidectomy, with or without compartmental neck dissection), with cervical LN/s suspected as DTC recurrency.
- •In the OR arm:
- •Patients operated for known DTC (partial or total thyroidectomy, with or without compartmental neck dissection).
- •Patients operated for DTC recurrency ('completion' and/or compartmental neck dissection).
排除标准
- •Pregnant women
研究组 & 干预措施
Formal/standard evaluation of a suspected cervical lymph node
Patient with cervical lymph node suspected as differentiated thyroid carcinoma metastasis will be evaluated according to the current accepted American Thyroid Association Guidelines.
Two clinical scenarios, for each one of them the formal evaluation is described below:
- Fine needle aspiration Clinic (a patient with known or suspected differentiated thyroid carcinoma is evaluation for suspicious cervical lymph node): the formal evaluation will include cytology and formal thyroglobulin measurement from the needle washout.
- Operating room (evaluation of suspicious cervical lymph node found during partial or complete thyroidectomy in patient with known or suspected differentiated thyroid carcinoma): the formal evaluation will include frozen section and/or final histology.
Point of care assay for thyroglobulin (POC-Tg) evaluation of a suspected cervical lymph node
Patient with cervical lymph node suspected as differentiated thyroid carcinoma metastasis will be evaluated using the study kit: Novel rapid POC-Tg.
Two clinical scenarios, for each one of them the performance of the study kit (POC-Tg) will be valuated in parallel to the formal evaluation:
- Fine needle aspiration Clinic (a patient with known or suspected differentiated thyroid carcinoma is evaluation for suspicious cervical lymph node): the suspected cervical lymph node will be evaluated using the POC-Tg in parallel to the formal evaluation.
- Operating room (evaluation of suspicious cervical lymph node found during partial or complete thyroidectomy in patient with known or suspected differentiated thyroid carcinoma): the suspected cervical lymph node will be evaluated using the POC-Tg in parallel to the formal evaluation.
干预措施: Point of care assay for thyroglobulin (POC-Tg) evaluation of a suspected cervical lymph node (Device)
结局指标
主要结局
Accurate diagnosis of suspicious cervical lymph node in the operating room being benign or malignant
时间窗: Up to 1 year following POC-Tg assessment
Sensitivity and specificity of the POC-Tg for the detection of DTC metastases to cervical LN compared to the current accepted evaluation
Accurate diagnosis of cervical lymph node in the FNA clinic being benign or malignant
时间窗: Up to 1 year following POC-Tg assessment
Sensitivity and specificity of the POC-Tg for the detection of DTC metastases to cervical LN compared to the current accepted evaluation
次要结局
未报告次要终点
研究者
Uri Yoel MD
Dr.Uri Yoel
Soroka University Medical Center