Clinical Value of the MRI Combined With SCC-Ag for the Diagnosis of High-grade Cervical Squamous Neoplasia (Cervical Intra-epithelial Neoplasia Grades 2 and 3 (CIN 2/3))
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- the number of cases whose combined diagnosis of MRI and SCC Ag for the non-menopausal group.
研究概览
简要总结
The study aimed to identify the clinical value of Magnetic Resonance Imaging examination (MRI)combined with serum squamous cells carcinoma antigen (SCC-Ag) in women with high-grade squamous intraepithelial lesion (cervical intraepithelial neoplasia grades 2-3 (CIN 2-3)).
详细描述
186 female patients with the HSIL(CIN2-3) were included in this study and followed up from the time of admission. All patients underwent colposcopy examination, MRI, SCC-Ag, loop electrosurgical excision procedure (LEEP), extrafascial hysterectomy, or radical hysterectomy. Pathological findings of the patient's tissues were used as the final diagnostic criteria. On the one hand, we compared the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of MRI+SCC-Ag, LEEP of the menopausal group, and non-menopausal group. On the other hand, evaluating the accuracy of MRI combined with SCC-Ag examination in diagnosing HSIL(CIN2-3) by receiver-operating characteristic curve (ROC)．
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 26 Years 至 82 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •No previous history of cervical lesions
- •TCT and HPV test results suspected cervical lesions
- •Further colposcopy showed HSIL or CIN 2-3
- •All selected patients underwent MRI, serological tests for SCC-Ag levels, LEEP, or radical hysterectomy
排除标准
- •Patients with receiving cold knife conization
- •Patients with skin squamous cell carcinoma or previous history of cancer
- •Pregnant women
- •Patients with serious heart, liver, kidney, blood system and autoimmune diseases
结局指标
主要结局
the number of cases whose combined diagnosis of MRI and SCC Ag for the non-menopausal group.
时间窗: 20 days
In non-menopausal women, the number of cases whose combined diagnosis of MRI and SCC Ag consistent with the final pathological results
The number of cases whose combined diagnosis of MRI and SCC Ag In postmenopausal women
时间窗: 20 days
In postmenopausal women, the number of cases whose combined diagnosis of MRI and SCC Ag consistent with the final pathological results
次要结局
未报告次要终点