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临床试验/NCT02602717
NCT02602717Unknown不适用

The Evaluation of the Diagnostic Properties of Intra-operative In-situ Thyroglobin Levels of Cervical Lymph Nodes, in the Discrimination Between Benign and Malignant Lymph Nodes in Thyroid Cancer: a Prospective Multicentre Study.

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2013年2月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
110
试验地点
1
主要终点
thyroglobin levels dosage

研究概览

简要总结

Cytological examination of punctured lymph nodes is the gold standard for confirming metastatic lymph node spread of differentiated thyroid cancers. In order to increase the diagnostic sensitivity of fine-needle cyto-punctured lymph nodes, an assessment of Tg levels of the aspirate could be included. Although this technique has been well proven, many uncertainties remain, especially with regards to a pathological cut-off value and its clinical utility when the thyroid is still intact. This uncertainty is mainly due to discordancy between low Tg levels found in cytopunctured lymph nodes with normal cytology, and their final histopathological analyses.

To eliminate this uncertainty, cyto-punction will be performed intra-operatively after localizing and isolating the target lymph nodes for assessment of cytology and Tg values. The thyroid gland might be present or absent (already operated) depending on the case. Finally, the cyto-punctured lymph nodes will be excised for complete histopathological analysis. In order to determine whether the Tg values are appropriate in cases where the thyroid is intact, a control group has been included (First operation for thyroid cancer or benign pathology). To eliminate the possible iatrogenic risks of lymph node dissection and resection in patients for whom it is not indicated, only lymph nodes found along the incision path for neuromonitoring of the recurrent laryngeal nerve (performed systematically) will be analysed and excised.

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

入选标准

  • Subject aged 18 years and above, male or female, with a valid social security coverage;
  • Subject willing to participate in the study with a signed informed consent;
  • Subject being operated for a papillary thyroid cancer, re-operated for persistent/relapsed lymphadenopathy, or for benign thyroid pathology (Graves disease, multinodular goitre, toxic nodule);
  • Subject having had a blood test for plasma Tg levels and circulating anti-Tg antibodies in the week preceding the surgical intervention.

排除标准

  • Subjects presenting with thyroid cancers of non follicular origin

研究组 & 干预措施

thyroid cancer

Experimental

干预措施: lymph nodes cyto-punction (Other)

结局指标

主要结局

thyroglobin levels dosage

时间窗: 7 days

次要结局

  • Plasma Tg levels(7 days)
  • Detection of tumor cells by staining with May-Grünwald Giemsa of lymph node cytology elements :(15 days)
  • circulating anti-Tg antibodies levels(7 days)
  • Detection of tumors by lymph node histology(15 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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