Clinical Study on the Accuracy of Novel Serological Risk Model in Early Diagnosis of Cholangiocarcinoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Malignant/Benign status of enrolled suspected cholangiocarcinoma patients by pathological examination
研究概览
简要总结
This is a prospective, observational and exploratory clinical study. The object of this study is to evaluate the accuracy of a novel serological risk model on blood samples in early diagnosis of cholangiocarcinoma patients.
详细描述
A reliable and accurate preoperative tool capable of early diagnosing malignant cholangiocarcinoma is lacking and urgently needed for clinical practice. This study proposes to establish and evaluate a novel serological risk model on blood samples for non-invasively diagnosing cholangiocarcinoma. The study includes the construction of capable novel serological risk model and the validation of the diagnosis model.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient must sign an informed consent form;
- •Age 18-75 years old, both male and female;
- •ECOG performance status score (PS score) 0-2;
- •Cholangiocarcinoma with resectable tumor lesions;
- •Complete the blood collection before treatment;
排除标准
- •Accompanied with other primary malignant tumors;
- •Patients who have neoadjuvant chemotherapy or other tumor-targeted therapies;
- •Incomplete serological examinations or medical history data.
结局指标
主要结局
Malignant/Benign status of enrolled suspected cholangiocarcinoma patients by pathological examination
时间窗: 4 weeks
The pathological examination results of each enrolled patient will be recorded
Malignant/Benign status of enrolled suspected cholangiocarcinoma patients evaluated by the novel serological risk model
时间窗: 2 weeks
The novel serological risk model will be constructed for differential malignant/benign diagnosis
次要结局
未报告次要终点