Role of Cytomorphometry and BRAFV600E Immunocytochemistry With a Cytologic Diagnosis "Suspicious for Papillary Thyroid Carcinoma"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Role of Cytomorphometry and BRAFV600E Immunocytochemistry with a Cytologic Diagnosis "Suspicious for Papillary Thyroid Carcinoma"
研究概览
简要总结
Thyroid nodules (TNs) are a common finding, detected by ultrasound in about 70% of healthy individuals, with women being four times more affected. While most TNs are benign, the primary clinical goal is to exclude malignancy, which occurs in 4-6.5% of cases. Risk factors for TNs include age, gender, iodine imbalance, family history, and radiation exposure. Thyroid cancer incidence has risen due to improved diagnostic methods such as ultrasound, FNAC, CT, MRI, and PET scans.
Papillary thyroid carcinoma (PTC) is the most common thyroid malignancy (90%), followed by follicular, Hurthle cell, medullary, and anaplastic carcinomas. Most thyroid cancers have an excellent prognosis, with a 5-year survival rate of 98.6%. FNAC is the gold standard for diagnosing TNs, and the Bethesda system (TBSRTC) categorizes cytology results into six groups with varying malignancy risks. The "suspicious for malignancy" category (74% risk) includes mostly suspicious papillary thyroid carcinoma (SPTC), but false positives occur, especially in cases of Hashimoto's thyroiditis.
SPTC diagnosis can be challenging, leading to potential overtreatment. To improve diagnostic accuracy, additional techniques like detailed ultrasonographic criteria, intraoperative frozen section, and molecular marker testing are used. Cytomorphometric analysis has been explored for distinguishing benign from malignant thyroid lesions, assessing nuclear size, shape, and chromatin patterns. Most studies have focused on histological sections, but applying morphometry to cytology could enhance automated and accurate diagnoses.
Molecular studies reveal that PTCs primarily arise from MAPK pathway mutations, with BRAFV600E being the most common (60%). This mutation is strongly associated with aggressive tumor behavior and recurrence. BRAFV600E testing combined with FNAC significantly improves diagnostic accuracy, increasing sensitivity from 76.71% (mutation testing alone) to 96.62% when combined with cytology. This integration has reduced false-negative PTC diagnoses and facilitated targeted therapies.
详细描述
Thyroid nodules are common clinical finding in routine daily medical and surgical practice. They are discovered by ultrasonography in about 70% of clinically healthy individuals. Thyroid nodules are four times more prevalent in women and up to 90% of cases are caused by benign conditions.
The main target of clinical management of thyroid nodules is exclusion of malignancy (4-6.5% of all thyroid nodules), assessment of pressure symptoms and evaluation of thyroid dysfunction .
Many risk factors were identified related to development of thyroid nodules including advanced age, gender, increased or decreased iodine, family history of cancer or polyposis and history of head and neck radiation. The most common thyroid nodules are colloid nodules, Hashimoto's thyroiditis, subacute thyroiditis, cysts, follicular adenoma and thyroid cancers.
Regarding thyroid malignant tumors, the incidence of thyroid cancer increased over the past decades in the United States and internationally. It's the 7th most common cancer in the general population and the 5th most common in women. The incidence of thyroid cancer is about 3 times higher in women than men and it increases from adolescence to middle age with the peak around 55 years in women and 65 years in men then decreasing with older age.
The increase of number of cancer cases is caused by increased diagnosis resulting from the widespread use of diagnostic tools including ultrasonography imaging, fine needle aspiration cytology , computed tomography , magnetic resonance imaging and fluorodeoxyglucose positron emission tomography. In addition to the increase in the exposure to the etiologic factors as ionizing radiation during childhood and obesity.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only Papanicolaou (PAP) and Hematoxylin & Eosin (H&E) stained FNAC smears diagnosed as suspicious for papillary thyroid carcinoma will be included in the study.
- •Only FNAC smears with well-preserved nuclear morphology will be included in the study.
- •Smears with histopathological slides.
排除标准
- •FNAC smears lacking histopathological confirmation.
- •Smears with extensive nuclear overlap and poor morphology.
- •Smears obscured by inflammation, blood, or mucoid material.
- •Smears exhibiting cellular degenerative changes or drying artifacts.
- •Any patient with missing data.
结局指标
主要结局
Role of Cytomorphometry and BRAFV600E Immunocytochemistry with a Cytologic Diagnosis "Suspicious for Papillary Thyroid Carcinoma"
时间窗: 3 months
* To evaluate the risk of malignancy in TNs diagnosed as SPTC by FNAC. * To characterize the different morphometric parameters in cases diagnosed cytologically as SPTC. * To evaluate the immunocytochemical expression of BRAFV600E in cases diagnosed cytologically as SPTC. * To evaluate the utility of cytomorphometric analysis and BRAFV600E immune-staining alone or in combination in upgrading the diagnostic accuracy of SPTC cases.
次要结局
未报告次要终点
研究者
Salwa Mohamed
Principal Investigator
Assiut University