Observation of Exhaled VOC Biomarkers Characteristics in Admitted Women With Breast Ultrasound BI-RADS 4 Grade
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Exhaled VOC Biomarkers
研究概览
简要总结
- Explore VOCs indicators that can effectively distinguish between benign and malignant breast diseases.
- The accuracy of VOCs indicators and ultrasound 4a/4b/4c diagnosis will be compared in determining benign and malignant diseases based on pathological gold standards.
详细描述
Inclusion Criteria:
Ultrasound examination within 3 months clearly indicates that breast lesions are BI-RADs4a/4b/4c Surgical treatment within one week after Exhaled VOC test informed consent form should be signed
Exclusion Criteria:
Male Women who have been diagnosed as breast cancer by puncture Individuals with unclear BI-RADs level information by breast ultrasound, including but not limited to BI-RADs 4/3-4a/4a-b/4b-c Pregnant or lactating women A positive smoking history within one year Medical history of malignant tumor, including but not limited to breast cancer (excluding skin basal cell carcinoma) The past history of metabolic diseases, including diabetes, gout, etc Respiratory diseases that have been clearly diagnosed in the past, such as asthma and chronic obstructive pulmonary emphysema, are not suitable for participation in the study Previously diagnosed digestive system diseases, such as Helicobacter pylori positivity and gastric ulcers, are not suitable for participation in the study Combination application of drugs related to the treatment of elderly dementia Possible cases which researchers believe it is not suitable for this clinical research
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ultrasound examination within 3 months clearly indicates that breast lesions are BI-RADs4a/4b/4c
- •Surgical treatment within one week after Exhaled VOC test
- •informed consent form should be signed
排除标准
- •Women who have been diagnosed as breast cancer by puncture
- •Individuals with unclear BI-RADs level information by breast ultrasound, including but not limited to BI-RADs 4/3-4a/4a-b/4b-c
- •Pregnant or lactating women
- •A positive smoking history within one year
- •Medical history of malignant tumor, including but not limited to breast cancer (excluding skin basal cell carcinoma)
- •The past history of metabolic diseases, including diabetes, gout, etc
- •Respiratory diseases that have been clearly diagnosed in the past, such as asthma and chronic obstructive pulmonary emphysema, are not suitable for participation in the study
- •Previously diagnosed digestive system diseases, such as Helicobacter pylori positivity and gastric ulcers, are not suitable for participation in the study
- •Combination application of drugs related to the treatment of elderly dementia
- •Possible cases which researchers believe it is not suitable for this clinical research
结局指标
主要结局
Exhaled VOC Biomarkers
时间窗: 1 year
The relationship between exhaled VOC and breast cancer grading will be studied. 168 patients with With Breast Ultrasound BI-RADS 4 Grade were enrolled. Exhale gas was collected and tested using mass spectrometer. Exhaled VOC biomarkers characteristics in admitted women with breast ultrasound BI-RADS 4 grade will be investigated.
次要结局
未报告次要终点