Study of the Predictive Value of a Signature of microRNA in Thyroid Cytologies of Undetermined Type
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 71
- 试验地点
- 6
- 主要终点
- Area under receiver operating characteristic (ROC) curve of the microRNA signature
研究概览
简要总结
The aim is to validate a signature of microRNA (micro Ribonucleic acid) based in a first exploratory study allowing the stratification of the cytologies of indeterminate type and to study and select others. In a first step, the teams will focus on standardising the pre-analytical stages and defining a threshold of positivity. The results of microRNA signature on a cohort of 70 patients will be compared with the ultrasound and then histological data of the resection specimen.
详细描述
Morphological analysis of fine-needle aspiration cytology (FNAC) under ultrasound classifies thyroid nodules in 6 categories (Bethesda classification). The diagnostic approach is codified by the Society of Endocrinology and for cytologies of indeterminate type (Bethesda 3, 4 and 5), surgery of thyroid nodules is currently recommended. However, only 15.9% of the cytologies classified Bethesda 3, 26.1% of the Bethesda IV and 75.2% of the Bethesda V are actually cancers in the definitive histological analysis on surgical resection.
Thus, new tools for predicting the risk of thyroid nodule malignancy need to be developed.
To date, various risk stratification biomarkers have been reported in the literature but have not been validated in independent cohorts, thus excluding their implementation in daily practice.
In addition, two commercial nucleic acid tests are proposed at a cost not compatible with generalized diffusion. The first approach is based on a next generation sequencing analysis of a target gene panel at the nucleotide sequence or transcribed level. The second alternative combines an analysis at level 1) of the deoxyribonucleic acid (DNA) with the search for somatic variations such as mutations in oncogenes or the presence of fusion genes, and 2) microRNA with the measurement of their level of expression.
Due to their stability, their ability to modulate the expression of various messenger RNA, microRNA are an attractive line of research.
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
- •Man or woman whose Age is ≥ 18 years
- •Patient requiring ultrasound for thyroid nodule scanning with established indication of FNAC
- •Patient with Bethesda 3, 4 and 5 thyroid nodule
- •Informed patient and signed informed consent received
- •Patient affiliated to a French medical coverage system
排除标准
- •Patient under guardianship, curatorship or safeguarding of justice
- •Patient whose medical or psychological conditions do not permit them to complete the study or to sign the consent,
- •Patient with metastatic cancer distinct from thyroid cancer
- •Patient who has stopped treatment (chemotherapy / immunotherapy) for cancer for less than 6 months.
研究组 & 干预措施
Signature of microRNA
Signature of miRNA in patients with Thyroid Cytologies of undetermined type and with a Bethesda classification 3, 4 or 5
干预措施: Signature of microRNA for patients with bethesda classification 3, 4 or 5 (Diagnostic Test)
结局指标
主要结局
Area under receiver operating characteristic (ROC) curve of the microRNA signature
时间窗: 24 months
次要结局
- Sensitivity of the test (microRNA)(24 months)
- Specificity of the test (microRNA)(24 months)
- Positive predictive value (PPV) of the test (microRNA)(24 months)
- Negative predictive value (NPV) of the test (microRNA)(24 months)