Prospective Study of Serum Marker LncRNA RP5-977B1 for Differentiating Benign
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Benign nodule
研究概览
简要总结
Based on previous studies, this project intends to use prospective studies to select patients identified by imaging as pulmonary nodules to explore the potential of RP5-977B1 in differentiating benign and malignant pulmonary nodules, construct diagnostic models combined with clinical protein tumor markers, compare the diagnostic efficacy of the two, and finally determine the sensitivity and specificity of markers through pathological results. It provides a new content for the diagnosis of benign and malignant pulmonary nodules.
详细描述
For the purpose of clinical diagnosis, disease monitoring, treatment or prognosis assessment, patients with pulmonary nodules may need to draw blood for routine laboratory tests several times during diagnosis and treatment. There may be some blood samples to be discarded after the completion of routine tests. This clinical trial will only use these remaining blood samples as research samples. The samples collected in this part of the study were serum samples from patients with pulmonary nodules, and 50 subjects were planned to be enrolled.
Admission criteria: ① Pulmonary nodules were detected by imaging and surgically resected.
② Age 15-75 years old.
-
Surgery or puncture is to be performed for pathological diagnosis.
-
Adequate hematological function and liver and kidney function reserve. ⑤ The sample has no hemolysis, sufficient margin, and the source record is clear and can be checked.
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
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulmonary nodules were detected by imaging and surgically resected.
- •Age 15-75 years old.
- •Surgery or puncture is to be performed for pathological diagnosis.
- •Adequate hematological function and liver and kidney function reserve. ⑤ The sample has no hemolysis, sufficient margin, and the source record is clear and can be checked.
排除标准
- •Patient samples have hemolysis, have been contaminated, have been placed for too long, have insufficient sample allowance, and record mixed samples.
- •History of malignant tumor. ③ Serious underlying diseases and complications may affect systemic treatment. ④ Can not guarantee to receive blood tests on time. ⑤ Received anti-tumor Chinese medicine, immunization, chemotherapy and other treatments within 2 weeks.
结局指标
主要结局
Benign nodule
时间窗: A week
Pathological findings determined that the nodules were benign in the patient
Tumor
时间窗: A week
Pathological findings identified the nodules as malignant tumors in the patient
次要结局
未报告次要终点