To Reveal the Predictive Value of Preoperative Hemogram Parameters and BRAF Molecular Test in Predicting Malignancy in Cases With Thyroid Nodules Detected by Bethesda 3 Cytology.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean Platelet Volume (MPV) (fL)
研究概览
简要总结
The main hypothesis of this study is that preoperative hemogram parameters can be used as biomarkers for malignancy in patients with thyroid nodule Bethesda 3 cytology.
The secondary hypothesis is that BRAF molecular testing has a high predictive value in predicting malignancy in patients with thyroid nodule Bethesda 3 cytology.
Primary outcome: Preoperative hemogram parameters. Secondary outcome: BRAF positivity.
详细描述
The main hypothesis of this study is that preoperative hemogram parameters can be used as biomarkers for malignancy in patients with thyroid nodule Bethesda 3 cytology.
The secondary hypothesis is that BRAF molecular testing has a high predictive value in predicting malignancy in patients with thyroid nodule Bethesda 3 cytology.
Primary outcome: Preoperative hemogram parameters. Secondary outcome: BRAF positivity. This study aims to reduce unnecessary thyroidectomies, thyroidectomy complications and treatment costs due to Bethesda 3 cytology.
The age and gender of all patients to be included in the study will be recorded. Mean Platelet Volume (MPV), Neutrophil/lymphocyte Ratio (NLR), Platelet/Lymphocyte Ratio (PLR) and Lymphocyte/Monocyte Ratio (LMR) will be recorded in preoperative hemograms. Nodule sizes detected by preoperative Bethesda III cytology will be recorded. The sizes of nodules with preoperative AUS cytology after thyroidectomy, determined as a result of pathological examination, will be recorded. Patients with malignant cytology will be divided into papillary thyroid carcinoma (PTC), Follicular Thyroid Carcinoma (FTC), and tumor sizes will be recorded. Among the patients included in the study, BRAF molecular testing will be performed on the preoperative cytology of 25 patients whose thyroidectomy materials were reported to be malignant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between the ages of 18 -75
- •Patients who were diagnosed with Bethesda III as a result of preoperative FNAC and decided to undergo thyroidectomy
排除标准
- •Patients over 18 years old and under 75 years old
- •Patients with malignancy detected in another focus with preoperative Bethesda III FNAC
- •Detection of malignancy in another focus other than the nodule with Bethesda III cytological result after thyroidectomy
- •Failure to obtain preoperative hemogram results Patients who do not agree to participate in scientific studies for BRAF testing
结局指标
主要结局
Mean Platelet Volume (MPV) (fL)
时间窗: 1 week
Mean Platelet Volume (MPV) (fL) values will be taken and recorded in the preoperative hemogram parameters of all patients.
Lenfosit/Monosit Ratio (LMR)(103/µL)
时间窗: 1 week
Lymphocyte/Monocyte Ratio (LMR) will be calculated by taking the Lymphocyte (103/µL) and Monocyte (103/µL) values in the preoperative hemogram parameters of all patients.
Platelet/Lenfosit Ratio (PLR)(103/µL)
时间窗: 1 week
Platelet/lymphocyte ratio (PLR) will be calculated by taking the Platelet (103/µL) and Lymphocyte (103/µL) values in the preoperative hemogram parameters of all patients.
Neutrophil/lenfosit Ratio (NLR)(103/µL)
时间窗: 1 week
Neutrophil/lymphocyte ratio (NLR) will be calculated by taking the Neutrophil (103/µL) and Lymphocyte (103/µL) values in the preoperative hemogram parameters of all patients.
次要结局
- BRAF molecular test(1 week)