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临床试验/NCT05521594
NCT05521594已完成不适用

Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience

Qena Oncology Center2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
2
主要终点
Incidence of false negative results by FNAC

研究概览

简要总结

Thyroid gland diseases are the second most common endocrine disease following diabetes mellitus(1). Thyroid nodules are common disorders with a prevalence ranged from 4 to 7% in adult population, 5%-30% are malignant [1].Fine-needle aspiration cytology (FNAC) is an easy, cost-effective test for cancer diagnosis, and its use has markedly decreased the number of unnecessary thyroid surgeries(2).

详细描述

it should be noted that FNAC cannot differentiate between benign and malignant follicular neoplasms.differentiation between follicular adenoma and follicular carcinoma is only possible after thyroid lobectomy.[2,3] In addition, a study of FNAC showed that 68% of the cases diagnosed by FNAC as follicular neoplasm turned out to be the follicular type of papillary carcinoma, indicting a considerable overlap between benign and malignant neoplasms.[4] Incidental findings of thyroid nodules have increased exponen¬tially in recent years, mostly due to the widespread application of high-resolution ultrasound (US) to the thyroid [5].Several in¬ternational scientific societies have established clinic-radiolog¬ical guidelines for the diagnosis and the management of thy¬roid nodules [2,3]. The American College of Radiology identifies 5 radiological risk levels and recommends US-guided fine-nee¬dle aspiration cytology (US-FNAC) of high-suspicion nodules if 10 mm or larger, and of nodules with a low risk for malignan¬cy only if larger than 25 mm [2]. According to the European Thyroid Association Guidelines (EU-TIRADS), nodules with no high-risk features (oval-shaped, isoechoic/hyperechoic with smooth margins) should be considered at low risk and FNA performed only if greater than 20 mm, while high-risk nodules greater than 10 mm should undergo FNAC, with possible FNAC also in 5-10 mm nodules if highly suspicious [3].

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Thyroid diseases
  • Multi nodullar
  • single nodules
  • diffuse goiter
  • Thyroid diseases underwent FNAC Then Thyroid surgery

排除标准

  • Patients with no diagnostic FNAC

结局指标

主要结局

Incidence of false negative results by FNAC

时间窗: 10 days

false negative that diagnosed by FNAC not malignant but proved malignancy after surgical excion

Percentage of Total number of true results of FNAC to the total number of cases

时间窗: 10 days

accuracy of FNAC

Incidence of true positive results of FNAC after thyroidectomy

时间窗: 10 days

Accuracy of FNAC in thyroid nodules compared to to surgical specimen : QOC experience

Percentage of malignant thyroid nodules not observed by FNAC

时间窗: 10 days

type of thyroid malignancy not observed by FNAC

次要结局

未报告次要终点

研究者

发起方
Qena Oncology Center
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mohamed Ahmed Orabi

specialist of surgical oncology at Qena Oncology Center

Qena Oncology Center

研究点 (2)

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